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Current & Recent Clinical Trials

Scientists at AIDS Research Alliance have conducted over 150 clinical trials for industry and the National Institutes of Health.  Examples of recent or on-going clinical trials include the following studies:

Merck Sharp & Dohme
7/2011 to present
Protocol 247: A study to evaluate the effect of metal cation-containing antacids on raltegravir pharmacokinetics in HIV-infected subjects on a stable raltegravir-containing regimen.
Pfizer, Inc.
3/2011 to present
Protocol A4001098: A multicenter, randomized, blinded, placebo-controlled study to evaluate the safety of Maraviroc in combination with other antiretroviral agents in HIV-1 infected subjects co-infected with Hepatitis C and/or Hepatitis B virus.
Hoffman-La-Roche, LTD.
9/2011 to present
Protocol NV20234: A double-blind, randomized, stratified, multi-center trial evaluating conventional and high dose Oseltamivir in the treatment of immuno-compromised patients with influenza.
Salix Pharmaceuticals, Inc.
7/2011 to present
Protocol CFHD3092: A Phase 3, multicenter, open-label evaluation of the safety and tolerability of Crofelemer in HIV-positive subjects with diarrhea.
Geovax, Inc.
6/2011 to present
Protocol GV-TH-01: A Phase 1 clinical trial to evaluate the safety and immunogenicity of a prime-boost vaccine regimen of pGA2/JS7 DNA and MVA/HIV62B in HIV-infected adults with suppressed viremia who started antiretroviral therapy within eighteen months of a negative HIV antibody test.
Tobira Therapeutics, Inc.
4/2011 to present
Protocol 652-2-202: A Phase 2b randomized, double-blind, double-dummy trial of 100 or 200mg once-daily doses of Cenicriviroc (CVC, TBR-652) or once-daily EFV, each with open-label FTC/TDF in HIV-1 infected, antiretroviral treatment-naïve, adult patients with only CCR5-tropic virus.
GlaxoSmithKline, Co.
11/2010 to present
Protocol ING111762: A Phase III randomized, double-blind study of the safety and efficacy of GSK1349572 50mg once daily versus Raltegravir 400mg twice daily, both administered with an investigator-selected background regimen over 48 weeks in HIV-1 infected, integrase inhibitor-naïve, antiretroviral therapy-experienced adults. 
GlaxoSmithKline, Co.
10/2010 to present
Protocol ING114467: A Phase III, randomized, study of the safety and efficacy of GSK1349572 plus abacavir-lamivudine fixed-dose combination therapy administered once daily compared to Atripla over 96 weeks in HIV-1 infected antiretroviral therapy naïve adult subjects. 
Pfizer, Inc.
11/2009 to present
Protocol A40081244: A randomized, double-blind, placebo-controlled, parallel-group, multi-center trial of Pregabalin versus placebo in the treatment of neuropathic pain associated with HIV neuropathy. Site: AIDS Research Alliance.
National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS) & DAIDS Regulatory Affairs Branch (RAB)
04/09 to 02/13
Protocol HVTN 505: Phase 2, randomized, placebo-controlled trial to evaluate the safety and effect on post-HIV acquisition viremia of a multiclade HIV-1DNA plasmid vaccine followed by a multiclade HIV-1 recombinant adenoviral vector vaccine in HIV-uninfected, adenovirus type 5 neutralizing antibody negative, circumcised men and transgender women, who have sex with men.
Merck & Co., Inc., & Division of AIDS, NIH
12/08 to 03/10
Protocol HVTN 504: Observational follow-up of adult participants enrolled in the Step Study (Merck V520 Protocol 023/HVTN 502), a 3-dose regimen of the Merck MRK Ad5 HIV-1 gag/pol/nef vaccine or placebo.
Progenics Pharmaceuticals
04/08 to 07/09
Protocol PRO 140 2101: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of PRO 140 by Subcutaneous Administration in Adult Subjects with Human Immunodeficiency Virus Type 1 Infection.
Avexa Ltd.
01/08 to 10/09
Protocol AVX-301: A Phase 2b/3, Randomized, Double Blind, Dose Confirming Study of the Safety, Efficacy and Tolerability of Apricitabine Versus Lamivudine in Treatment-Experienced HIV-1 Infected Patients with the M184V/I Mutation in Reverse Transcriptase.
Theratechnologies, Inc.
09/07 to 06/10
Protocol TH9507-CTR-1012: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 MG Dose of TH9507, A Growth Hormone Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation.
Napo Pharmaceuticals, Inc.
06/07 to 04/11
Protocol NP303-101: Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Two-Stage Study to Assess the Efficacy and Safety of Crofelemer 125 mg, 250mg, and 500 mg Orally Twice Daily for the Treatment of HIV-Associated Diarrhea (ADVENT Trial).
Schering-Plough Research Institute
06/07 to 08/08
Protocol P04889: Vicriviroc in Combination Treatment with an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E4).
Numico Research, B.V.
01/07 to 04/09
Protocol 100157, BITE study: A Randomized, Double-blind, Controlled Study on the Effect of One Year Administration of a Nutritional Concept on Immunological Status in HIV-1 Positive Adults not on Antiretroviral Therapy.
Theratechnologies, Inc.
12/06 to 09/08
Protocol TH9507-CTR-1011: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 MG Dose of TH9507, a Growth Hormone Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation.
POM Wonderful
08/06 to 08/10
Protocol POM ARA011: A Phase I/II, Proof-of-Concept, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Effects of Punica Granatum (Pomegranate) Juice on the Indices of Quality of Life in HIV Positive Patients.
Pharmexa, Inc.
06/06 to 06/08
Protocol EP HIV-1090: A Phase I Safety and Immunogenicity Study of the Pharmexa-Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) Administered Using a Biojector® 2000 Needle Free Immunization Device in HIV-1 Infected Individuals Receiving Potent Combination Antiretroviral Therapy (ART).
NeurogesX, Inc.
05/06 to 04/08
Protocol C119: A Multicenter Randomized, Double-Blind Controlled Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy.
Tibotec
11/05 to 07/06
Protocol TMC114-C226: Early Access of TMC114 in Combination with Low-Dose Ritonavir (RTV) and Other Antiretrovirals (ARVs) in Highly Treatment Experienced HIV-1 Infected Volunteers with Limited or No Treatment Options.
Pfizer Inc.
10/05 to 04/08
Protocol A0081095: An Open-Label, Extension Safety and Efficacy Trial of Pregabalin in Subjects with Neuropathic Pain Associated with HIV Neuropathy.
NeurogesX, Inc.
08/05 to 06/07
Protocol C118: A Multicenter, Open-Label, Phase II Study of NGX-4010 for the Treatment of Neuropathic Pain in Patients with Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN).
US National Institutes of Health
08/05 to 06/09
Protocol U19/ARA010: Rectal Health, Behaviors and Microbicide Acceptability
Pfizer, Inc.
05/05 to 02/08
Protocol A0081066: A Randomized, Double-Blind, Placebo- Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated with HIV Neuropathy.
Theratechnologies, Inc.
05/05 to 06/07
Protocol TH9507/III/LIPO/010: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 MG Dose of TH9507, a Growth Hormone Releasing Factor Analog, in HIV Patients with Excess of Abdominal Fat Accumulation.
Tibotec
05/05 to 06/06
Protocol TMC114-C214: A Phase III Randomized, Controlled, Open-Label Trial to Compare the Efficacy, Safety, and Tolerability of TMC114/RTV versus LPV/RTV in Treatment-Experienced HIV-1 Infected Subjects.
Merck & Co., Inc.
03/05 to 04/11
Protocol V526-001: A Phase I Dose Ranging Study of the Safety, Tolerability and Immunogenicity of a 3-Dose Regimen of The MRKAd5 HIV-1 Trigene and the MRKAd6 HIV-1 Trigene Vaccines Alone and in Combination in Healthy Adults.
Serono, Inc.
1/05 to 11/05
A Phase III, Multi-Center, Open-Label, 12-Week, Follow-up Safety and Efficacy Study of Serostim® (mammalian cell-derived recombinant human growth hormone, r hGH) in Subjects with Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS).
Merck & Co., Inc.
1/05 to 06/09
Protocol 005: Double-blind, Randomized, Dose-Ranging Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies.
Merck & Co., Inc.
12/04 to 06/07
Protocol 004: Multicenter, Double-Blind, Randomized, Dose Ranging Study to Compare the Safety and Activity of MK-0518 Plus Tenofovir and Lamivudine (3TC) Versus Efavirenz Plus Tenofovir and Lamivudine(3TC) in ART-Naïve, HIV-Infected Patients.
Bristol-Myers Squibb
11/04 to 09/06
Protocol BMS AI424-128: A Phase IV, Multi-Center, Cross-Sectional Study to Evaluate the 150L Substitution Among Subjects Experiencing Virologic Failure on a HAART Regimen Containing Atazanavir (ATV).
Merck & Co., Inc.
11/04 to 04/09
ProtocolV520-023: A Multicenter Double-blind, Randomized, Placebo-controlled Phase II Proof of Concept Study to Evaluate the Safety, and Efficacy of a 3 Dose Regimen of the Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef Vaccine (MRKAd5 HIV-1 gag/pol/nef) in a Prime-Boost Regimen in Adults at High Risk of Infection.
Alimentary Health
10/04 to 05/07
Protocol ARA 009: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Bifidobacterium Infantitis Therapy in the Treatment of HIV-Associated Diarrhea.
SpectraDigital Corporation
8/04 to 03/08
Protocol ARA008: A Phase I Pilot Proof of Concept Study to Determine the Efficacy of an in vitro Diagnostic Device, HIV SpectraPoint, in HIV Positive Patients with Prior Resistance to any Antiretroviral Drug.
Tibotec
7/04 to 06/05
Protocol TMC125-C223: A Randomized, Controlled, Partially blinded, dose-finding trial of TMC125, in HIV-1 infected subjects with documented genotypic evidence of resistance to currently available NNRTIs and with at least three primary PI mutations.
Tibotec
7/04 to 12/04
Protocol TMC114-C202: A Phase II, Randomized, Partially Blinded, 48-week Trial to Investigate Dose Response of TMC114/RTV in 3-Class-Experienced HIV-1 Infected Subjects.
Serono
5/04 to 01/06
Protocol 24380: A Phase III, Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Safety and Efficacy of Serostim (mammalian cell-derived recombinant human growth hormone r-hGH) in the Treatment and Maintenance of Human Immunodefiency Virus-associated Adipose Redistribution Syndrome (HARS).
Bristol-Myers Squibb
7/04 to 06/06
Protocol BMS AI424-103: “A Phase IIIB, Open-Label, Randomized, Multicenter Study Comparing the Antiviral Efficacy, Safety, and Effect on Serum Lipids of Atazanavir/Ritonavir Versus Lopinavir/Ritonavir, each in Combination with Tenofovir and either Didanosine EC or Stavudine XR in HIV-1 Infected Subjects Receiving a NNRTI-Containing HAART Regimen who are Experiencing their First Virologic Failure.
Merck & Co., Inc.
7/03 to 02/10
Protocol 016: A Phase I Dose-Ranging Study of the Safety, Tolerability, and Immunogenicity of the Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef Vaccine (MRKAd5 HIV-1 gag/pol/nef) in a Prime-Boost Regimen in Healthy Adults.
NeurogesX, Inc.
7/03 to 05/06
Protocol C107: A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Painful HIV-Associated Distal Symmetrical Polyneuropathy.
Agouron Pharmaceuticals, Inc. (A Pfizer Co.)
4/03 to 07/05
Protocol: A4301010: An Open-Label Study of the Pharmacokinetics, Safety and Efficacy of Optimized Viracept Therapy as a Component of HAART in Treatment-Naïve Subjects.
Bristol-Myers Squibb
3/03 to 1/05
Protocol AI424-067: A Phase IIIB, Open-Label, Randomized, Multicenter Study Evaluating the Effect on Serum lipids Following a Switch to the Protease Inhibitor (PI) Atazanavir in HIV-1 Infected Subjects Evidencing Virorlogic Suppression on Their First PI-Based Antiretroviral Therapy.
NeurogesX, Inc.
3/03 to 11/03
Protocol C109: An Open-Label Pilot Study of High-Concentration Capsaicin Patches in the Treatment of Painful HIV-Associated Neuropathy.
Agouron Pharmaceuticals, Inc. (A Pfizer Co.)
2/03 to 10/03
Protocol A4311022: A Rollover Study for Subjects Continuing Treatment With Open-Label Capravirine Who were enrolled in Study A4311006.
Bristol-Myers Squibb
2/03 to 02/05
Protocol AI266-406: VEST-QD: A Phase IV, Open-Label, Randomized, Multicenter Study Switching HIV-1 Infected Subjects With a Viral Load < 50 Copies/mL on a First PI-Based Regimen to an Efavirenz Substitution Regimen.
Agouron Pharmaceuticals, Inc. (A Pfizer Co.)
12/02 to 10/03
Protocol A4311006: A Phase II, Randomized, Double-Blind, Dose-Ranging Study of Capravirine (AG1549) In Combination With Kaletra and at Least 2 Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Subjects Who Have Failed Antiretroviral Regimens Containing Protease Inhibitors, Nonnucleoside Reverse Transcriptase Inhibitors, and Nucleoside Reverse Transcriptase Inhibitors.
Savient Pharmaceuticals, Inc.
12/02 to 03/05
Protocol C0603: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study to Evaluate the Efficacy and Safety of Prosaptide Over 6 Weeks of Treatment for the Relief of Neuropathic Pain Associated With HIV-1.
Agouron Pharmaceuticals, Inc. (A Pfizer Co.)
10/02 to 9/03
Protocol A4311002: A Double-Blind, Randomized, Placebo-Controlled Study of 2 Doses of Capravirine (AG1549) in Combination With VIRACEPT and Two Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Patients Who Have Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen.
Integrative Health Consulting
9/02 to 6/03
Protocol IHC 1001c: Broad Spectrum Micronutrient Supplementation in HIV-Infected Patients Who Develop Peripheral Neuropathy While Taking Stavudine or Didanosine Antiviral Therapy.
Shionogi/GlaxoSmithKline
6/02 to 1/03
Protocol ITG20001: A Phase II, Randomized, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Doses of S-1360 Versus Placebo Over 10 Days.
Bristol-Myers Squibb
4/02 to 07/05
Protocol AI455-110: A Study to Compare Long-Term Safety and Tolerability of Stavudine (d4T) Extended Release (ER) Versus Conventional (Immediate Release, IR) Formulations, Each in Combination with Lamivudine (3TC) and Efavirenz (EFV) in Subjects Who Have Completed AI455-096 and AI455-099.

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