Phase Ia Study of ChAd63/MVA PvDBPMar 2013
This is an open label phase Ia study, to assess the safety of two novel malaria vaccines, ChAd63 PvDBP, with or without MVA PvDBP. Heterologous prime-boost with ChAd63-MVA is, to our knowledge, one of the most potent T cell-inducing subunit vaccine regimens which can importantly also induce antibodies. Previous clinical trials using this regimen expressing ME-TRAP, AMA1 & MSP1, have shown that administering ChAd63 as a prime followed 8 weeks later by MVA as a boost is a very immunogenic schedule (32-34). For this reason, and to provide comparability with previous ChAd63-MVA trials, we propose to use a similar administration schedule.
ICCM of Common Childhood Diseases: Mozambique and Uganda (inSCALE)Mar 2013
The aim of the inSCALE project is to test the effect of innovative approaches to increase coverage of integrated community case management, which provides community based-care for diarrhoea, pneumonia and malaria, resulting in more children receiving timely and appropriate care for these three most common childhood illnesses
Study to Evaluate a HIV Drug for the Treatment of HIV InfectionMar 2013
The primary purpose of this study is to study the safety and tolerability of a HIV drug and to evaluate a decrease of HIV-1 virus level in blood after treatments in HIV-1 infected patients
DRV/r + RPV QD: Efficacy and Toxicity ReductionFeb 2013
Clinical approach to HIV infection treatment is based on the use of highly active antiretroviral therapies (HAART) and recent national and international guidelines for guiding HIV therapy recommend the use of triple-combination therapy using antiretrovirals with 2 nucleos(t)ide inhibitors [N(n)RTI] as backbone plus a third drug to be chosen among a boosted protease inhibitor (PI/r), a nonnucleoside inhibitor (NNRTI) or an integrase inhibitor (II). In spite of evident efficacy of HAART, as demonstrated by survival increasing, long term side effects, as for example the impact on renal function, remain principal problem. In patient with risk factor for renal disease, a reduction of eGRF (estimated Glomerular Filtration Rate) between 90 and 60 mL/min/1,73 m2 could be already considered as a risk condition [1,2]. Efficacy of HAART, with increase of media survival and the parallel decrease of mortality, has underlined the necessity to reflect on long term HAART effects . There are many evidences of HAART-related toxicity that, in spite of the necessity of a life-saving therapy, focus on the additional costs of this situation, in terms of health as well as in terms of economic costs. Particular attention has been focused on the impact of some drugs on renal function, as tenofovir, especially on tubule, without forgetting the modification of lipid and bone metabolisms. According to further studies which have evidenced the potential of some recently introduced molecules [4,5], the investigators had the need to realize a study to deepen the feasibility of a dual-therapy that permit to exclude NRTIs from the backbone, with the aim to prevent NRTIs-related long-term toxicity. The investigators have designed a prospective randomized controlled trial, open-label, with a duration of 96 weeks, to compare the efficacy of a dual-therapy based on rilpivirine 25mg plus darunavir 800mg/ritonavir 100mg QD, in HIV-positive subjects with suppressed viremia from at least 3 months. In fact, there are a few data about association of these drugs, which it has been shown to be safe, well tolerated, and with a strong pharmacological synergy, without nucleos(t)idic backbone, while the necessity to minimize the costs toxicity-related is becoming increasingly compelling. According to clinical experience and literature data, the investigators hope this study shows positive results in term of immune-virological efficacy, as well as in term of decrease of VACS index - a complex parameter which has the purpose to quantify general organic decay - and markers of lipid and bone metabolism, in group which receives dual-therapy versus the group with standard therapy. These results could stimulate further studies on less aggressive and however effective therapeutic regimens, with more sustainable biological and economic costs.
Congenital Transmission of Lineages I and II of Trypanosoma CruziFeb 2013
T. cruzi has been divided into two main lineages: T. cruzi I (TcI) and T. cruzi II (TcII, including all non-TcI). TcI is predominant in Mexico and Central America, while TcII (non-TcI) is predominant in most of South America, including Argentina. In recent studies from Argentina, the risk of congenital transmission has been estimated to vary between 2.6 percent and 7.9 percent. By contrast, we know very little about the congenital transmission of TcI. It has been suggested that congenital transmission of T. cruzi is strain related, and there is an urgent need to know if TcI transmits differently than TcII (non-TcI). Our primary hypothesis is that congenital transmission rates are different for TcI versus TcII. Our secondary hypothesis is that the characteristics of T. cruzi infected mothers (e.g., age, parity, transmission in previous pregnancies) and their exposure to vectors are different in regions where TcI is predominant versus regions where TcII (non-TcI) is predominant. To test these hypotheses, we propose to conduct a prospective study to enroll at delivery 13,000 women in Mexico, 7,500 women in Honduras, and 10,000 women in Argentina. We will measure transmitted maternal T. cruzi antibodies in cord blood, and, if the results are positive, we will identify infants who are congenitally infected by performing parasitological examinations on cord blood and at 4-8 weeks, and serological follow-up at 10 months. We will also perform standard PCR, real-time quantitative PCR, and T. cruzi genotyping on maternal blood, standard PCR and T. cruzi genotyping on the cord blood of congenitally infected newborns, and serological examinations on siblings. We will estimate the exposure to vectors in the household. In addition, we will measure prenatal outcomes among infected and uninfected infants with seropositive mothers, and the birth weight of their siblings. The specific aims of this study are: 1) To determine the rate of congenital transmission of TcI compared to TcII (non-TcI); 2) To compare the T. cruzi infected mothers' characteristics and exposure to vectors in regions where TcI is predominant and regions where TcII (non-TcI) is predominant; and 3) To describe the birth outcomes of infected and uninfected infants born to TcI and TcII seropositive women.
Immunization With Plasmodium Falciparum Sporozoites Under Chloroquine or Chloroquine/Azithromycin Prophylaxis (MMV)Jan 2013
This study will assess the superior protective immunity of the combination of chloroquine and azithromycin prophylaxis under Chemoprophylaxis Sporozoites (CPS) immunization versus a standard chloroquine prophylactic regimen.
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected SubjectsJan 2013
This is an Open-label Phase 3 study in subjects with chronic Genotype 1, 2, 3, and 4 HCV-infection who are co-infected with HIV-1. A total of 220 HCV subjects who are co-infected with HIV-1 will be enrolled into a single arm and treated with oral SOF 400 mg QD plus weight based RBV (1000 or 1200 mg/day) BID for 12 weeks or 24 weeks. The study population will include HCV genotype 1, 2, 3, and 4 HCV treatment naive subjects (including IFN ineligible) and HCV genotype 2 and 3 HCV treatment experienced subjects who have failed prior therapy with PEG/RBV. Approximately 20% of the subjects enrolled will have evidence of compensated cirrhosis at Screening.
The Effect of Antacids and Multivitamins on RaltegravirJan 2013
This study seeks to address the question of whether antacids or multivitamins influence the pharmacokinetics of raltegravir when co-administered. The aim of this study is to optimise the dosing of raltegravir when co-administered with antacids or multivitamins.
Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve AdultsJan 2013
The purpose of this study is to evaluate the efficacy of a single-tablet regimen (STR)containing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus a STR containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment naïve adult subjects as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48.
Optimization of Controlled Human Malarial Infection by Injection of P. Falciparum Sporozoites in Non-Immune AdultsJan 2013
The study is designed to establish the best dose to safely infect healthy individuals with Plasmodium falciparum sporozoites (PfSPZ) by injection. The goal of this study is to achieve infections in human volunteers with infection rates of 100% and pre-patent periods of less than 12 days.
A randomized, pilot clinical trial designed to compare, in human immunodeficiency virus infected patients who never have received antiretroviral therapy, the evolution of cerebral function and the neurocognitive efficient after 24 weeks of treatment with 2 regimens of highly efficacy antiretroviral treatment with different levels of central nervous system penetration.Nov 2012
Changes in the levels of N-acetyl-aspartate (NAA) in the basal brain ganglia
A Phase I/IIa Sporozoite Challenge Study to Assess the Efficacy of Candidate Combination Malaria Vaccine Approaches using the ChAd63 and MVA vectors encoding the antigens ME-TRAP, CS and AMA1.Nov 2012
This is a clinical trial in which healthy volunteers will be administered experimental malaria vaccines. One group of volunteers will receive a vaccination composed of a mixture of the ChAd63 ME-TRAP and ChAd63 CS vaccines, followed by another vaccination 8 weeks later with a mixture of the MVA CS and MVA ME-TRAP vaccines. Another group will receive a vaccination composed of a mixture of the ChAd63 ME-TRAP, ChAd63 CS and ChAd63 AMA1 vaccines, followed by another vaccination 8 weeks later with a mixture of the MVA CS, MVA ME-TRAP and MVA AMA1 vaccines. The principal research objective is to measure how well each of these two new malaria vaccine strategies act to prevent malaria disease. This is called efficacy. We will measure it by infecting volunteers with malaria and seeing whether the vaccines change how long it takes for malaria disease to develope.
A Dose-escalation Study to Investigate Safety and Toleration of OZ439Oct 2012
A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration of OZ439 OD for 3 days to healthy male and female volunteers. The study aims: To determine the safety and tolerability of ascending doses of OZ439 OD for three days. To assess pharmacokinetic parameters of ascending doses of OZ439 given OD. To identify the maximum tolerated dose of OZ439 administered.
A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve WomenOct 2012
To evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV-1 infected, antiretroviral treatment-naïve adult women as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48
A phase IV, open-label single-arm study investigating the pharmacokinetics and pharmacodynamics of the antiretroviral combination of rilpivirine and ritonavir-boosted darunavir in therapy-naive HIV-1 infected patients.Oct 2012
To see how well the study regime suppresses the HIV-1 virus after 48 weeks of therapy.
PRe-exposure Option for reducing HIV in the UK: an open-label randomisation to immediate or Deferred daily Truvada for HIV negative gay menSep 2012
The purpose of this pilot is to determine whether it is feasibile to conduct a large trial in the UK to determine whether the immediate inclusion of anti-retroviral pre-exposure prophylaxis (PrEP) as part of the HIV risk reduction package for men who have sex with men is clinically effective and cost-effective in reducing the risk of acquiring HIV.
Efficacy and pharmacokinetics of a switch from a regimen consisting of emtricitabine, nevirapine and tenofovir to rilpivirine, emtricitabine and tenofovir in virologically suppressed HIV-1 infected patients.Aug 2012
To evaluate the safety of a switch from nevirapine to rilpivarine.
Adjuvanting Viral Vectored Malaria Vaccines With Matrix MAug 2012
ChAd63 METRAP and MVA METRAP are investigational vaccines for malaria which have been studied in clinical trials for 4 years, and 10 years, respectively. These vaccines are inactivated viruses which have been modified so that they cannot reproduce in humans. Genetic information has been added to make them express proteins of the malaria parasite so that they stimulate an immune response against malaria. This trial examines whether a compound called Matrix M™ can be used in efforts to improve on how well the vaccines work at preventing malaria. Matrix M™ is a vaccine adjuvant, a compound used to improve the immune responses to vaccines. In this trial, Matrix M™ will be combined with each of the vaccines. The objectives are to assess the safety of the vaccines when combined with Matrix M™, and to determine what effect Matrix M™ has on the immune responses to the vaccines.
A prospective, observational study to examine the effects of ageing on the clinical outcomes of people living with HIV in England and Ireland.Aug 2012
To analyse the incidence and outcomes of intercurrent illnesses (other illnesses occurring or recurring) in older HIV-positive people and their relationship with demographic( for example age, gender, ethnicity employment, housing and relationship status) and clinical factors (for example any details of past or present illnesses and treatments). Also history of illnesses within the family.
Evolution of serologic biomarkers and diastolic function and segmentary contractility determined by echocardiography after treatment in Chagas diseasesAug 2012
Chagas disease (CD), caused by Trypanosoma cruzi, is endemic to Latin America, and is of emerging importance in non-endemic countries because migration of people infected with T. cruzi. Current methods for diagnosis of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce severe side-effects, and their effectiveness cannot be properly evaluated. Reliable biomarkers for prognosis, early diagnosis and effectiveness of treatment will be investigated.
Optimized Phase III Trial of Immuno-stimulation with Maraviroc, a CCR5 antagonist, combined with Anti Retroviral Therapy (cART) in advanced, Late diagnosed HIV-1 infected patients with an AIDS-defining event and/or CD4 counts below 200 cells/mm3.Jul 2012
To demonstrate the clinical benefit of the adjunction of Maraviroc to a combination of antiretroviral therapy in naïve and late diagnosed HIV-1 infected patients. The clinical benefit is the reduction of the occurrence of a composite outcome consisting of new AIDS-defining event (ADE), Non B or C events, serious non-AIDS events, IRIS and death.
Effect of maraviroc on the transcription of the human immunodeficiency virus type 1 (HIV-1) in resting CD4+ T lymphocytes in patients on antiretroviral treatment with suppressed viral loadJul 2012
To determine if treatment with MVC during a short period of time in patients with previously suppressed viral load by antiretroviral treatment leads to an increase in transcription of latent virus
Investigation of a novel intervention in Acute HIV infection (AHI) on long term latent HIV reservoir size: A pilot study of antiretroviral therapy plus immunoglobulin in AHIJul 2012
To investigate whether reactivation of HIV using immunoglobulin in individuals with AHI and virologically suppressed with ART, will reduce HIV viral reservoir at week 48.
Pharmacokinetic interactions between Telaprevir and not powered Atazanavir with ritonavir in co-infected patients with HIV and HCV genotype 1 in treatment for chronic liver disease by HCVJun 2012
To assess changes in plasma pharmacokinetic parameters (Cmax, Cmin, AUC0-8, t 12, and Cl) of Telaprevir 750 mg/8h administered with Atazanavir 200 mg/8h not powered, taking as reference the observed pharmacokinetic parameters when given with Atazanavir/ritonavir 300/ 100 mg per day or Raltegravir.
Controlled Human Malarial Infection by Intravenous Injection of Plasmodium Falciparum Sporozoites in Non-Immune AdultsJun 2012
The study is designed to establish the best dose to safely infect healthy individuals with Plasmodium falciparum sporozoites (PfSPZ) via intravenous (IV) injection.
TAILoR – (TelmisArtan and InsuLin Resistance in HIV): A Dose-Ranging Phase II Randomised Open-Labelled Trial of Telmisartan as a strategy for the Reduction of Insulin Resistance in HIV-Positive Individuals on Combination Antiretroviral Therapy (cART)May 2012
The trial will assess whether telmisartan can reduce insulin resistance (reduced response to insulin) in HIV-positive individuals being treated with combination antiretroviral therapy (cART). Primary objective: To determine the effect of telmisartan on insulin resistance in HIV-positive individuals on combination antiretroviral therapy using HOMA-IR (Homeostatic Model Assessment - Insulin Resistance) as a measurable, validated surrogate marker of insulin resistance.
A randomised, prospective study, assessing changes in cerebral function in treatment naive HIV-1 infected subjects commencing either boosted atazanavir with Truvada or boosted darunavir with maraviroc and KivexaMay 2012
When commencing antiretroviral therapy (anti-HIV therapy) for the first time, improvements in the function of the brain are frequently observed. For example memory and concentration may improve. However, whether these improvements may differ between different anti-HIV therapies is largely unknown. The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period.
The Safety and Efficacy of The Histone Deacetylase Inhibitor Panobinostat for Purging HIV-1 from The Latent Reservoir (CLEAR) StudyApr 2012
A decrease of >0.5 log10 from baseline to week 16 in the size of the latent HIV-reservoir as measured by copies of total proviral HIV-DNA per 10⁶ CD4+ T-cells in HIV-infected patients on suppressive HAART
A phase IV, open-label, single centre, single-arm, pilot study to assess Cerebrospinal fluid INflammatory markers after Addition of Maraviroc to MONotherapy darunavir/ritonavir – The CINAMMON Study SSAT046Apr 2012
To investigate changes from week 12 to week 36 in levels of inflammation within the fluid that surrounds the Central Nervous System, called cerebrospinal fluid or CSF, when maraviroc is taken along with regular darunavir/ritonavir monotherapy for 24 weeks.
Investigating the effect of Maraviroc on microbial translocation in HIV-1 infected individuals who are receiving antiretroviral therapyApr 2012
To determine whether the addition of a CCR5 inhibitor to a stable ART regimen reduces microbial translocation (as determined by plasma bacterial 16s DNA)
A multicenter randomised opened study to assess the efficacy and safety of the withdrawal of nucleos/tide analogues in HIV-1-infected subjects with complete or intermediate resistance to these analogues, multitreated with virological suppressionMar 2012
To assess the safety and efficacy at 48 weeks of withdrawing NRTIs with intermediate or complete resistance in subjects with previous virological failure and a suppressed viral load for > 6 months.
Drug Interaction Study of PSI-7977 and Antiretroviral Therapy(ART) Combinations in Human Immunodeficiency Virus and Hepatitis C Virus (HIV/HCV) Co-infected Patients.Mar 2012
This is a drug interaction study between PSI-7977 and antiretroviral therapy (ART) combinations of Efavirenz, Tenofovir and Emtricitabine; Efavirenz, Zidovudine and Lamivudine; Atazanavir/r, Tenofovir and Emtricitabine; in patients co-infected with HIV and HCV. This is an open-label study of approximately 24 healthy HIV/HCV co-infected patients. The study consists of 3 cohorts of 8 patients in each cohort. Patients will be treated with PSI-7977 for 7 days in combination with their ART regimen that the subject has been receiving to manage their HIV infection.
A Phase 3b Randomized, Open Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI/r) plus Emtricitabine/Tenofovir Fixed-Dose Combination (FTC/TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients.Jan 2012
To evaluate the non-inferiority of EVG/COBI/FTC/TDF relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI/r) plus FTC/TDF in maintaining HIV 1 RNA < 50 copies/mL at Week 48 (Snapshot Analysis) in virologically suppressed, HIV 1 infected subjects.
Effects of losartan and antiretroviral regimen containing raltegravir in fibrosis inflammation mediators, cardiovascular risk and neurocognitive disorders in HIV infected patients previously effectively treated.Jan 2012
Proportion of patients with decreased collagen deposition in TL equal to or greater than 50%.
Population Pharmacokinetics in Benznidazol-treated adults with Chronic Chagas Disease. Benznidazol Pharmacokinetics and adverse reactions relationship.Dec 2011
To study population pharmacokinetics in Benznidazol-treated adult patients with Chronic Chagas Disease to get information to optimaze drug doses.
A Phase IIIb, randomized, open-label study of the safety and efficacy of GSK1349572 (dolutegravir, DTG) 50 mg once daily compared to darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily each administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral naïve adult subjects.Nov 2011
To demonstrate the non-inferior antiviral activity of DTG 50 mg administered once daily compared to DRV/r 800 mg/100 mg once daily over 48 weeks in HIV-1 infected therapy-naïve subjects.
A phase IV, randomized, open label, cross-over, intervention trial to investigate the effect of the switch of lopinavir-ritonavir to raltegravir on endothelial function, chronic inflammation, immune activation and HIV replication below 50 copies/mlNov 2011
To assess the effect of the switch of lopinavir-ritonavir to raltegravir on endothelial function.
A multicenter, randomized, double blind, comparative trial of maraviroc + darunavir/ritonavir versus emtricitabine/tenofovir + darunavir/ritonavir for the treatment of antiretroviral naïve HIV infected patients with CCR5 tropic HIV 1Oct 2011
To assess whether maraviroc (SelzentryTM, Celsentri®) administered once daily (QD) is non inferior to a reference regimen of emtricitabine/tenofovir administered QD each in combination with darunavir/ritonavir in the treatment of antiretroviral naïve HIV 1 infected subjects as measured by the proportion of subjects with HIV 1 RNA below the limits of assay detection (<50 copies of HIV 1 RNA per milliliter of plasma) at Week 48.
Pro-Bono 2- A prospective study of loss of bone mineral density in patients with HIV over time: implications for clinical practice and therapeutic options: Vitamin D sub study.Oct 2011
To determine the effects of vit D supplementation on markers of the immune system, specifically CD4+CD25+ T-regulatory cells
Chloroquine for Malaria in PregnancySep 2011
The purpose of this study is to test prevention strategies for pregnancy-related malaria. Researchers will compare different malaria treatments and treatment schedules which include chloroquine therapy (weekly doses versus being dosed twice during pregnancy for 3 days each time) to the standard practice of preventive treatment intervals in pregnancy (with the drug sulfadoxine-pyrimethamine given twice during pregnancy).
Assessment of Therapeutic Response to Benznidazole in patients with Chronic Chagas Disease by Measuring Plasma Parasite Load and the Specific Immune Response against Trypanosoma cruzi. A Randomized, open label, Pilot Clinical TrialJul 2011
To compare the evolution of the parasite load at baseline and during therapy with benznidazole and in the following 16 months after therapy, in treated and untreated patients. To compare the evolution of the specific immune response against T. cruzi at baseline and during therapy with benznidazole and in the following 16 months after therapy, in treated and untreated patients.
Time to Become Negative of Three Rapid Diagnostic Tests for MalariaMar 2011
The objective of this study is to estimate the proportion of positive tests in patients successfully treated for malaria (smear negative) at different time points in time after treatment, for three rapid diagnostic tests: SD Bioline Malaria Antigen P.f. (catalogue number: 05FK50-02-4), CareStart Malaria HRP2 (Pf) (catalogue number: G0141) and CareStart Malaria pLDH (PAN) (catalogue number: G0111). The study will be carried out in two settings with known low and high malaria transmission levels in order to provide guidance of interpretation of a RDT positive result depending on the intensity of malaria transmission.
The metabolic impact of Darunavir/ritonavir maintenance monotherapy after successful viral suppression with standard Atripla in HIV-1-infected patients (MIDAs).Nov 2010
This project aims to assess the potential long-term advantages of switching HIV patients from the standard therapy (Atripla) to a different regime of treatment (darunavir 800 mg / ritonavir 100 mg). This will be assessed by measuring Vitamin D levels, calcium and phosphate homeostasis (balance), kidney (tubular) function, bone turnover and bone mineralisation, and HIV disease progression in all the patients who take part in the study.
Bone Loss and Immune Reconstitution in HIV/AIDS (BLIR-HIV)Oct 2010
With the increasing age of people living with HIV/AIDS, age-induced osteoporosis is likely to be compounded by HIV/AIDS and HAART-associated bone loss. Mechanistically, osteoclasts the cells responsible for bone resorption form under the influence of the key osteoclastogenic cytokine Receptor- Activator of NF-KB (RANKL). The osteoclastogenic and proresorptive activities of RANKL are moderated by its physiological decoy receptor osteoprotegerin (OPG). Imbalance in the ratio of RANKL to OPG alters osteoclastic bone resorption and lead to osteoporosis. Activated T- and B-cells are a major source of RANKL, while normal physiological B-cells are a major source of OPG. T-cells regulate the production of OPG by B-cells. Thus changes in the immune system induced by HIV/AIDS and/or by HAART could affect B-cell and T-cells RANKL and OPG production. Indeed, data from our group shows that in an animal model of HIV/AIDS, the HIV-1 Transgenic rat, the development of osteoporosis is recapitulated as observed in HIV-infected patients, and B-cell OPG and RANKL production are concurrently down regulated and upregulated respectively. Furthermore, preliminary data in HIV-infected subjects suggests dramatic acute upswing in bone resorption following HAART initiation that peaks at 12 weeks and then declines. Based on these findings, the investigators hypothesize HAART associated bone loss is driven by immune reconstitution. Because this effect of HAART is dramatic in magnitude but short in duration, the investigators propose to apply antiresorptive agent (zoledronic acid, reclast®) to specifically spare patients from this dramatic but acute bone damage.
Evaluating Methods to Increase HIV Testing, Access to HIV Care, and HIV Prevention StrategiesJun 2010
This is a five-part study that will take place in the Bronx, NY, and Washington, D.C. The different components of the study will focus on increasing the number of people being tested for HIV, evaluating ways to link HIV-infected people to HIV care sites, evaluating methods to reinforce antiretroviral therapy (ART) adherence, and evaluating a counseling program that focuses on HIV prevention.
Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria (MalaRia)Jun 2010
The aim of the study is to compare both tolerance and efficacy of Malarone® and Riamet® in the treatment of uncomplicated imported malaria and to determine clinical and parasitological predictive factors associated with a less effectiveness. It's a multicentric, randomised study in adults with uncomplicated malaria. Treatment will be administered for 3 days, and patients will be followed for 28 days, to evaluate the therapeutic evolution. 640 patients will be included among 15 centres.
A randomised, double-blind, placebo-controlled, clinical trial to compare the safety and efficacy of reduced dose efavirenz (EFV) with standard dose EFV plus two nucleotide reverse transcriptase inhibitors (N(t)RTI) in antiretroviral-naïve HIV-infected individuals over 96 weeks.Apr 2010
To compare the safety and efficacy of standard (600mg qd) versus reduced dose (400mg qd) EFV as part of initial combination antiretroviral therapy (ART).
Intermittent Preventive Treatment Versus Scheduled Screening and Treatment of Malaria in Pregnancy (IPTp_IST)Mar 2010
The goal of this project is to determine whether in pregnant women who sleep under a long lasting insecticide treated bed net, screening and treatment at each scheduled antenatal clinic visit is as effective in protecting them from anaemia, low birth weight and placental infection as SP-IPTp.
Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Women (PROMOTE-PIs)Oct 2009
This study is an open-label, single site, randomized controlled trial comparing protease inhibitor (PI)-based antiretroviral therapy (ART) to non-PI based ART for HIV-infected pregnant and breastfeeding women of all CD4 cell counts at high risk of malaria. The study is designed to test the hypothesis that pregnant women receiving a PI-based ART regimen will have lower risk of placental malaria compared to pregnant women receiving a non-PI based ART regimen. The primary study endpoint of the study is placental malaria.
Strategic Timing of AntiRetroviral Treatment (START)Jun 2009
To determine whether early ART is superior to deferred ART in delaying the occurrence of a composite outcome consisting of AIDS* (AIDS with an asterisk include most traditional opportunistic conditions but exclude non-fatal esophageal candidiasis and chronic Herpes simplex) non-AIDS, or death from any cause
Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With MenMar 2009
The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex with men.
A Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 ReplicationFeb 2009
The investigators seek to determine whether Virco®TYPE HIV-1 provides benefits equivalent to those provided by local expert review.
Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive SubjectsApr 2008
A prospective, randomized, open-label pilot study to assess virologic suppression and immunologic recovery rates associated with a Two-drug antiretroviral regimen of Raltegravir and the protease inhibitor lopinavir/ritonavir (LPV/r) and Raltegravir and two nRTIs (emtricitabine/tenofovir) in HIV-1 infected treatment-naïve subjects.
A Phase II, Randomized, Placebo-Controlled, Multi-Center Study To Evaluate The Safety, Tolerability, Immunogenicity, And Antiretroviral Activity Of Dermavir (Lc002) Patch In Treatment-Naïve HIV-1-Infected PatientsAug 2007
To evaluate the safety and tolerability of the DermaVir patch (LC002) in antiretroviral therapy naïve adults infected with HIV-1. To establish a safe and well tolerated dosing regimen of the DermaVir patch (LC002) in antiretroviral therapy naïve adults infected with HIV-1.
Randomized, controlled, multicentric trial to evaluate efficacy and safety of the switch from a LPV/r based therapy to an ATV/r or a NVP based treatment in association with ABC/3TC, in HIV patient with undetectable viral loadFeb 2007
To compare the different incidence of virologic failure between the two groups after 12 months from randomization.
Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine with or without Tenofovir on the Pharmacokinetics of Atazanavir when given with Ritonavir in HIV-Infected Subjects. Revised Protocol 02 incorporating amendment 03 (Version 1.0, Date 09-Mar-2007) and amendment 04 (Version 1.0, Date 02-Jul-2007). And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 5.0, Date 14-Sep-2006).Oct 2006
To assess the effect of multiple-dose FAM BID on the multiple-dose PK of ATV/RTV in HIV-infected subjects when FAM is administered simultaneously (without TDF) or temporally separated (with TDF).
Effect of different meals on the pharmacokinetic profile of Saquinavir at steady state in HIV-infected patients treated with saquinavir/ritonavir 1000/100 mg bid.Oct 2006
To compare the pharmacokinetic profile of saquinavir at steady state in HIV-infected patients taking saquinavir/ritonavir 1000/100 mg with two different meals (low-fat and high-fat meals)