Clinical trials: Acquired Immune Deficiency Syndrome
Infection, Human Immunodeficiency Virus
Effect of Dolutegravir on Metformin Pharmacokinetics in Healthy Adult Subjects
This study will be a phase 1, open label, parallel group, three period crossover study to evaluate the effect of dolutegravir (DTG) on the steady state pharmacokinetics of metformin and on the safety and tolerability of…
- Trial name
- NCT02064374
- Testing
- Metformin 500 mg q12h, Dolutegravir 50 mg q24h, Dolutegravir 50 mg q12h
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections, Acquired Immunodeficiency Syndrome
Vicriviroc, a CCR5 Inhibitor, Added to an Optimized Antiretroviral Therapy for Previously Treated HIV (VICTOR-E2) (Study P04285
This is an international study of vicriviroc in 500 adult HIV-infected subjects who are failing standard antiretroviral therapy (ART). HIV must be of a certain type known as R5/X4-mixed tropic.
- Trial name
- NCT00243568
- Testing
- Vicriviroc
- Sponsor
- Merck Sharp & Dohme LLC
Infection, Human Immunodeficiency Virus
PENTA Fosamprenavir Study
Twice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated for the treatment of HIV-infected adults, adolescents and children of 6 years of age and above for use in combination with other…
- Trial name
- NCT01077635
- Testing
- Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV)
- Volunteers
- 1 people
- Sponsor
- ViiV Healthcare
Acquired Immunodeficiency Syndrome, HIV Infections
Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
This study will evaluate the efficacy of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)) single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus…
- Trial name
- NCT01533259
- Testing
- Stribild
- Where
- 9 sites in United States
- Volunteers
- 48 people
- Sponsor
- Gilead Sciences
Infection, Human Immunodeficiency Virus
A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects
This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.
- Trial name
- ING112276 (NCT00951015)
- Testing
- GSK1349572, efavirenz
- Where
- 35 sites in United States, France and 4 more
- Volunteers
- 208 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus
Pharmacokinetics, Safety and Tolerability Study of Abacavir/ Dolutegravir/ Lamivudine Fixed-dose Combination Tablets in Healthy Japanese Subjects
The abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) 600 milligrams (mg)/50 mg/300 mg fixed-dose combination (FDC) tablet is currently approved in the United States (US) and Europe.
- Trial name
- NCT02539576
- Testing
- ABC/DTG/3TC FDC tablet
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Real-world Insights of People With Human Immunodeficiency Virus (HIV) Infection
This study is designed to identify the burden associated with HIV and its treatment, and assess their health-related quality of life (HRQoL) by measuring key HRQoL domains, including satisfaction with treatment and care, and…
- Trial name
- RISE (NCT03400293)
- Testing
- Functional Assessment of HIV Infection, Patient Satisfaction Questionnaire, Symptom Distress Module
- Where
- United States
- Volunteers
- 1,184 people
- Sponsor
- ViiV Healthcare
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
Facial Lipoatrophy
Facial Lipoatrophy Correction Experience With SCULPTRA ("FACES" Study)
5 year, open-label study to evaluate safety of SCULPTRA on the signs of lipoatrophy of the face in at least 100 evaluable subjects with human immunodeficiency virus.
- Trial name
- FACES (NCT00360932)
- Testing
- SCULPTRA (poly-L-lactic acid injection)
- Where
- United States
- Volunteers
- 290 people
- Sponsor
- Bausch Health Americas, Inc.
Human Immunodeficiency Virus Type 1 (HIV-1)
Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents.
- Trial name
- Atazanavir (NCT01837719)
- Testing
- Atazanavir, Cobicistat, Atazanavir/Cobicistat FDC
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
HIV Infections
A Study of LXR015-1 in HIV-Infected Patients
To determine and compare the safety and tolerability of 3 doses of LXR015-1 in HIV-infected patients.
- Trial name
- NCT00002365
- Testing
- LXR015-1
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- LXR Biotechnology
Human Immunodeficiency Virus (HIV) Infections
Phase IIIb Study to Evaluate the Effectiveness and Safety of Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in Human Immunodeficiency Virus (HIV)-Infected Subjects Evidencing Virologic Suppression
The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced protease inhibitor therapy can maintain virologic suppression without a marked increase in virologic failure.
- Trial name
- OREY (NCT00337467)
- Testing
- Atazanavir + Ritonavir
- Where
- 7 sites in Spain
- Volunteers
- 61 people
- Sponsor
- Bristol-Myers Squibb
HIV Infections
A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation
This study will assess the relative bioavailability of the CAB DT formulation relative to that of the CAB IR formulation and to assess the effect of food on the CAB DT formulation.
- Trial name
- NCT05776108
- Testing
- Cabotegravir IR Formulation (reference), Cabotegravir DT Formulation (test 1), Cabotegravir DT Formulation (test 2)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV
This study investigates the use of VH3810109 with or without FTR to reduce the size and activity of the HIV viral reservoir in two sub-populations of people living with HIV: treatment-naïve adults (Population 1) and…
- Trial name
- ENTRANCE (NCT07053384)
- Testing
- VH3810109, Fostemsavir (FTR), SOC INSTI-based ART
- Where
- 41 sites in United States, Belgium and 4 more
- Volunteers
- 107 people
- Sponsor
- ViiV Healthcare
HIV Infections, Psoriasis
Treatment of Psoriasis Using Acitretin in HIV-Positive Patients
To determine the efficacy of acitretin in the treatment of psoriasis in HIV/AIDS patients. Etretinate, a retinoid, has proven successful in the treatment of HIV-infected patients with psoriasis, but it has an elimination…
- Trial name
- NCT00002143
- Testing
- Acitretin
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Hoffmann-La Roche
Infection, Human Immunodeficiency Virus
Food Effect Study With BMS-955176
The purpose of this study is to assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions.
- Trial name
- NCT02273947
- Testing
- BMS-955176
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Primary Immune Deficiency Disorder
Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)
Primary: Demonstrate the utility of an electronic data capture (EDC) system (CareExchange™) using infusion nurse and patient measured physical, quality of life (QOL), respiratory, laboratory, and disability assessments in…
- Trial name
- NCT01883921
- Testing
- Immunoglobulin Therapy
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- BriovaRx Infusion Services
HIV Infections
A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC
To compare effects on CD4 counts and serum viral RNA among HIV-seropositive, zidovudine (AZT)-experienced patients in three treatment arms: indinavir sulfate ( MK-639; Crixivan ) plus AZT plus lamivudine ( 3TC ) versus MK-639…
- Trial name
- NCT00002155
- Testing
- Indinavir sulfate, Lamivudine, Zidovudine
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infection
Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together
The aim of the study is to see if apricitabine or tipranavir affect the levels of each other in the blood (pharmacokinetic interaction) when they are dosed together.
- Trial name
- NCT00352066
- Testing
- apricitabine
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Avexa
HIV Infections
Study of Itraconazole in Patients With Advanced HIV Infection
To demonstrate a dosage regimen for intravenous itraconazole that produces a plasma concentration range comparable to that obtained after currently used oral dosages of itraconazole oral solution; and to obtain preliminary safety…
- Trial name
- NCT00002370
- Testing
- Itraconazole
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Janssen, LP