Clinical trials: HIV/AIDS and Infections
HIV Infections
A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past
To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients.
- Trial name
- NCT00002320
- Testing
- Lamivudine, Zidovudine
- Where
- 22 sites in United States, Canada and 1 more
- Volunteers
- 320 people
- Sponsor
- Glaxo Wellcome
HIV Infections
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN…
- Trial name
- PALISADE (NCT06134362)
- Testing
- CAB LA
- Where
- 33 sites in Argentina, Botswana and 10 more
- Volunteers
- 2,996 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Infections, Papillomavirus, Papillomavirus Vaccines
Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety and immunogenicity of Cervarix in HIV infected…
- Trial name
- NCT01031069
- Testing
- GSK Biologicals' HPV vaccine 580299, Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)
- Where
- 15 sites in Brazil, Estonia and 2 more
- Volunteers
- 873 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa
The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants.
- Trial name
- NCT00263666
- Testing
- Rotarix, Tritanrix-HB+Hib, Polio Sabin
- Where
- 6 sites in South Africa
- Volunteers
- 100 people
- Sponsor
- GlaxoSmithKline
Infection, Human Immunodeficiency Virus, HIV Infections
Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults
GSK2838232 is a novel HIV-1 maturation inhibitor (MI) that is being developed for the treatment of HIV-1 infection in combination with other antiretroviral therapy (ART).
- Trial name
- NCT03045861
- Testing
- GSK2838232, Cobicistat
- Where
- 14 sites in United States, Canada
- Volunteers
- 33 people
- Sponsor
- GlaxoSmithKline
HIV Infections, HIV Wasting Syndrome
A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
To evaluate the safety, antiviral and anti-TNF-alpha activity, and preliminary efficacy of thalidomide in reducing weight loss in patients with HIV wasting syndrome.
- Trial name
- NCT00002127
- Testing
- Thalidomide
- Where
- 13 sites in United States
- Volunteers
- 75 people
- Sponsor
- Celgene Corporation
HIV Infections
Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates
The purpose of the study is to study the effects of BMS-955176 on the single-dose PK parameters of probe substrates caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin
- Trial name
- NCT02578277
- Testing
- CYP and transporter probe substrates, BMS-955176, BMS-955176 plus CYP and transporter probe substrates
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Preexposure Prophylaxis
Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024)
The main purpose of the study is to evaluate the safety and tolerability of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who…
- Trial name
- Impower-024 (NCT04652700)
- Testing
- ISL, FTC/TDF, FTC/TAF
- Where
- 25 sites in United States, Brazil and 5 more
- Volunteers
- 494 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
EBV-induced Lymphomas, EBV-associated Malignancies
Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies
The purpose of this phase I/II trial is to study the side effects and best dose of biological therapy to treat patients at high-risk or with Epstein-Barr virus-associated lymphoma or lymphoproliferative disease.
- Conditions
- EBV-induced Lymphomas, EBV-associated Malignancies, Transplant Patients With EBV Viremia at High Risk of Developing a Recurrent EBV Lymphoma
- Trial name
- NCT00002663
- Testing
- Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Atara Biotherapeutics
HIV Infections
A Phase I Study of the Safety and Immunogenicity of Rgp 120/HIV-1IIIB Vaccine in HIV-1 Seropositive Adult Volunteers
To test the safety and immunogenicity of rgp 120/HIV-1IIIB vaccine in HIV-1 seropositive adult patients.
- Trial name
- NCT00001992
- Testing
- rgp120/HIV-1IIIB
- Where
- United States
- Sponsor
- Genentech, Inc.
Pharmacokinetics, Bioavailability
TMC278-TiDP38-C145: A Bioavailability Study in Healthy Adult Volunteers to Evaluate 3 Pediatric Formulations of TMC278 (a Solution, a Suspension, and Granules) Compared to an Adult Tablet Formulation
The purpose of this study is to evaluate how much and how fast a single, oral, daily 25 mg dose of TMC278 is absorbed into the body when administered as a solution, suspension, granules, or a tablet.
- Conditions
- Pharmacokinetics, Bioavailability, HIV-1
- Trial name
- NCT00812292
- Testing
- TMC278
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Pneumococcal Infections
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018)
This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults infected with HIV and to 2) describe the safety, tolerability, and immunogenicity of…
- Trial name
- PNEU-WAY (NCT03480802)
- Testing
- V114, Prevnar 13™, PNEUMOVAX™23
- Where
- 13 sites in United States, France and 3 more
- Volunteers
- 302 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults
Primary purpose of this study is to compare the efficacy and safety of two different nevirapine (Viramune) dosing regimens (once daily (QD) and twice daily (BID) application) and of atazanavir/ritonavir (Reyataz/Norvir), all on…
- Trial name
- NCT00389207
- Testing
- nevirapine bid, nevirapine qd, atazanavir
- Where
- 68 sites in Argentina, Germany and 8 more
- Volunteers
- 576 people
- Sponsor
- Boehringer Ingelheim
Infection, Human Immunodeficiency Virus, HIV Infections
A Study to Assess Relative Bioavailability and Food Effect of New Formulations of GSK2248761
This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects to assess the effect of up to three formulations on the relative bioavailability of GSK2248761 100mg administered with and…
- Trial name
- NCT01031472
- Testing
- GSK2248761 formulation 1, GSK2248761 reference formulation, GSK2248761 formulation 3
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir
The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor…
- Trial name
- NCT00002220
- Testing
- Indinavir sulfate, Efavirenz, Levocarnitine
- Where
- 11 sites in United States
- Volunteers
- 120 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Rega
To determine the effect of HIV-1 immunogen (Remune) on AIDS-free survival, defined as the time prior to development of an AIDS-defining condition or death.
- Trial name
- NCT00002359
- Testing
- HIV-1 Immunogen
- Where
- 54 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- The Immune Response Corporation
HIV Infections
Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers
The purpose of the study is to determine the safety and tolerability of PRO 140, an investigational anti-HIV drug, administered via intravenous infusion.
- Trial name
- NCT00110591
- Testing
- PRO 140
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- CytoDyn, Inc.
Human Immunodeficiency Virus 1
A Study to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Patients
The purpose of this study is to compare change of brachial artery flow mediated vasodilatation using Darunavir/Ritonavir (DRV/r) 800/100 mg once daily as a monotherapy (use of a single medication) versus a triple combination…
- Trial name
- MONARCH (NCT01391013)
- Testing
- Darunavir(DRV), Ritonavir, 2 nucleoside reverse transcriptase inhibitors (NRTIs)
- Volunteers
- 30 people
- Sponsor
- Janssen-Cilag S.p.A.
Healthy
Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination
The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of Emtricitabine (FTC) and Tenofovir alafenamide (TAF) when administered as a fixed-dose combination (FDC) with darunavir (DRV) and…
- Trial name
- NCT02475135
- Testing
- Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC, Elvitegravir /Cobicistat/Emtricitabine/Tenofovir alafenamide FDC, Darunavir
- Where
- Belgium
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Janssen Sciences Ireland UC
HIV Infections
A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients
This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an…
- Trial name
- AMICI (NCT00488059)
- Testing
- enfuvirtide [Fuzeon], Optimized background ARV, Integrase inhibitor
- Where
- 43 sites in United States, Puerto Rico
- Volunteers
- 29 people
- Sponsor
- Hoffmann-La Roche
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