Clinical Trials
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Sexual Health
New Methods to Measure the Immune Response to Hepatitis B Vaccine
Mar 2013Hepatitis B vaccine is a safe and effective vaccine used widely throughout the world. Because of this it is a useful vaccine in which to develop new methods for studying immune responses. Measuring the immune response to vaccines helps us to understand how they work and whether they are likely to protect any individual against infection. For most vaccines we measure the immune system's production of antibody after a vaccine has been given. The investigators want to develop new methods that give a far more detailed picture of the antibody response to vaccines than has previously been possible. These methods will investigate the genetic instructions used by each antibody producing cell to make antibody. These methods have the potential to give new insights into the way vaccines work, which could be applied to studying vaccines and vaccine schedules in the future.
Study to Evaluate a HIV Drug for the Treatment of HIV Infection
Mar 2013The 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
Evaluating the Safety and Priming Response of an HIV Vaccine Regimen in Healthy, HIV-Uninfected Adults
Feb 2013This study will evaluate the safety of and the body's immune response to experimental HIV vaccine regimens using different vaccine priming combination, and boosting with the vaccines NYVAC and AIDSVAX® B/E.
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues
Feb 2013This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. Data will be collected from patients treated according to the current Summary of Product Characteristics and local standard of care and regulations during 48 weeks of treatment and 24 weeks of follow-up.
DRV/r + RPV QD: Efficacy and Toxicity Reduction
Feb 2013Clinical 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 [3]. 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.
Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests (OPTISCREEN-III)
Feb 2013This is a pilot, monocentric, prospective, randomized control trial looking at the use of rapid tests as a part of normal care. The investigators will be testing for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Testing will be proposed to all persons seeking care at the Centre d'Accueil, de Soins et d'Orientation from the organization Médecin du Monde (CASO, MDM). Infection status of participants will be determined by either the standard test (ELISA) or rapid test. The choice between tests will be determined randomly. The overall goal is to determine the general acceptability and feasibility of rapid tests and to see if they can help individuals increase their awareness of infection status when compared to longer, routine methods of testing. In addition, results from these tests will allow the medical doctor to guide participants to appropriate care. All positive tests will be confirmed at a specialized hospital (Hôptial Saint-Antoine, Paris, France) and health-specific information will be obtained four months after testing.
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 Subjects
Jan 2013This 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 Raltegravir
Jan 2013This 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.
Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
Jan 2013This study aims to develop innovative immunological read-outs and new technologies in order to further characterise the early immune response and its kinetics as well as the adaptive immune responses to adjuvanted vaccines. This study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals' Adjuvant System.
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 Adults
Jan 2013The 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.
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 2012Changes in the levels of N-acetyl-aspartate (NAA) in the basal brain ganglia
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 Women
Oct 2012To 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 2012To 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 men
Sep 2012The 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 2012To evaluate the safety of a switch from nevirapine to rilpivarine.
A prospective, observational study to examine the effects of ageing on the clinical outcomes of people living with HIV in England and Ireland.
Aug 2012To 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.
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 2012To 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 load
Jul 2012To 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
Comparison of effectiveness of hepatitis B revaccination schemes in healthy non-responders
Jul 2012Study the efficacy of mounting a protective immunological response against hepatitis B infection in previous hepatitis B vaccine non-responders. In this trial 4 different Hepatitis B vaccines are investigated.
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 AHI
Jul 2012To 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 HCV
Jun 2012To 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.
An open, prospective, single arm study investigating efficacy and safety of human hepatitis B immunoglobulin Zutectra in liver transplanted patients - the ZEUS Study
Jun 2012To investigate the efficacy of Zutectra in orthotopic liver transplanted patients
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 2012The 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.
The effect of vitamin D supplementation on immune response following hepatitis B vaccine in incident and prevalent hemodialysis patients with vitamin D deficiency
May 2012The main objective of this trial is to evaluate whether vitamin D supplementation is able to ameliorate the response of vitamin D-deficient hemodialysis patients receiving hepatitis B immunization
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 Kivexa
May 2012When 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) Study
Apr 2012A 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
Evaluating the Safety of and Immune Response to HIV-MAG DNA Vaccine With or Without Plasmid IL-12 Adjuvant Delivered Intramuscularly Via Electroporation Followed by VSV-gag HIV Vaccine Boost in Healthy, HIV-Uninfected Adults
Apr 2012This study will evaluate the safety and tolerability of and immune response to an HIV DNA vaccine with or without plasmid IL-12 adjuvant, when given by EP and followed by a live vector vaccine given IM by needle and syringe in healthy, HIV-uninfected adults.
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 SSAT046
Apr 2012To 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 therapy
Apr 2012To 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 suppression
Mar 2012To 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 2012This 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.
Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine
Feb 2012The purpose of this study is to determine whether short-term Atorvastatin can increase the immunity response to hepatitis B vaccination in vaccine Nonresponders.
Entecavir and Peginterferon for Immune-Tolerant Adults With Chronic Hepatitis
Feb 2012To determine whether entecavir and peginterferon can be used to treat people in the immune-tolerant phase of chronic hepatitis B.
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 2012To 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 2012Proportion of patients with decreased collagen deposition in TL equal to or greater than 50%.
Lowering viral load with nucleos(t)ide analogues prior to peginterferon alfa-2b treatment to increase sustained response in HBeAg-positive chronic hepatitis B (PEGON-STUDY)
Dec 2011To investigate sustained HBeAg response to peg-interferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral load
Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus
Nov 2011Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes serum ALT in chronic hepatitis B patients (CHB) with few adverse effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this study: - the data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA > 6log10 copies/mL during late pregnancy and infants - Its efficacy in the reduction of HBV vertical transmission rate
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 2011To 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/ml
Nov 2011To assess the effect of the switch of lopinavir-ritonavir to raltegravir on endothelial function.
A Multi-center, Randomized, Open-label study for Induction of HBsAg decline using an add-on treatment of peginterferon alfa-2a in HBeAg-negative chronic hepatitis B patients treated with nucleos(t)ide analogues
Nov 2011To investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative chronic hepatitis B patients who are pretreated with NA enhances the degree of HBsAg decline.
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 1
Oct 2011To 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 2011To determine the effects of vit D supplementation on markers of the immune system, specifically CD4+CD25+ T-regulatory cells
Sexual Behavior in Head and Neck Cancer Patients
Jun 2011The goal of this behavioral research study is to learn if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16). Knowing this information could help doctors better teach patients about avoiding certain risk factors, which may help to prevent the disease.
Effects of Vitamin D supplementation on Vitamin D levels and immune activation in HIV infected individuals on antiretroviral therapy-A pilot study.
May 2011Investigate the role vitamin D supplementation on restoring vitamin D levels in HIV infected individuals on antiretroviral therapy.
A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon α-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)
Mar 2011The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (PEG) combination therapy for 48 weeks versus standard of care TDF monotherapy or PEG monotherapy for 48 weeks in non-cirrhotic CHB subjects as determined by loss of HBsAg.
The metabolic impact of Darunavir/ritonavir maintenance monotherapy after successful viral suppression with standard Atripla in HIV-1-infected patients (MIDAs).
Nov 2010This 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 2010With 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.
HIV-1 Resistance at Screening for HIV Prevention Studies
Sep 2010MTN-009 is a multi-site, cross-sectional study that will provide an estimate of the prevalence of ARV resistance in the population of women who present to study sites to be pre-screened or screened for participation in an HIV prevention trial. To date, a comprehensive surveillance of HIV drug resistance in newly diagnosed women of reproductive age has yet to be undertaken. The primary goal of MTN-009 is to assess the frequency of HIV drug resistance mutations among women who test HIV-positive when presenting to screen for participation in HIV prevention trials.
Evaluating Methods to Increase HIV Testing, Access to HIV Care, and HIV Prevention Strategies
Jun 2010This 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.
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 2010To compare the safety and efficacy of standard (600mg qd) versus reduced dose (400mg qd) EFV as part of initial combination antiretroviral therapy (ART).
Hepatitis B Surface Antigen(HBsAg) Loss in Chronic Hepatitis B Patients With Low Viral Load (LVL)
Sep 2009This is a three arm open-label prospective randomized controlled trial.
Strategic Timing of AntiRetroviral Treatment (START)
Jun 2009To 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 Men
Mar 2009The 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 Replication
Feb 2009The 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 Subjects
Apr 2008A 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.
Sexual Functioning in Cervical Cancer Survivors
Aug 2007Primary Objectives: 1. To assess the entire range of sexual functioning (desire, arousal, orgasmic capacity, dyspareunia, and sexual satisfaction) over the course of treatment and early follow-up in patients with local and locally advanced cervical cancer; 2. To assess general cancer-related QOL over the course of treatment and early follow-up in patients with local and locally advanced cervical cancer; 3. To characterize the relationship between sexual dysfunction and overall cancer-related QOL over time; and 4. To identify factors that may predict better sexual function outcomes in patients treated for cervical cancer.
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 Patients
Aug 2007To 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.
A Randomized, Double Blind Study Evaluating Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B
Jul 2007To compare the antiviral efficacy against hepatitis B virus (HBV) of tenofovir DF monotherapy versus tenofovir DF plus emtricitabine combination therapy
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 load
Feb 2007To compare the different incidence of virologic failure between the two groups after 12 months from randomization.
A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process
Nov 2006To describe the seroprotection rate (SPR) one month after the third dose of vaccine for a modified process hepatitis B vaccine in healthy adults (≥50 years of age).
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 2006To 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 2006To 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)
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