Clinical trials: HIV-1 Infections
HIV-1-infection
Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects
To assess the safety and tolerability of Elsulfavirine following administration of single oral ascending doses in HIV-negative, healthy subjects.
- Trial name
- NCT05165550
- Testing
- Elsulfavirine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Viriom
HIV, HIV Infections
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy
This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of…
- Trial name
- VOGUE (NCT05979311)
- Testing
- Dolutegravir, Lamivudine, Bictegravir
- Where
- 64 sites in Argentina, Belgium and 15 more
- Volunteers
- 463 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection
Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF
This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are…
- Trial name
- NCT02121795
- Testing
- FTC/TDF, F/TAF, Allowed third antiretroviral agent
- Where
- 78 sites in United States, Belgium and 5 more
- Volunteers
- 668 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART)
During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced immunological response and ultimately immune deficiency.
- Trial name
- IMID (NCT01704781)
- Testing
- Lenalidomide, Vacc-4X, rhuGM-CSF
- Where
- 4 sites in Germany
- Volunteers
- 36 people
- Sponsor
- Bionor Immuno AS
HIV Infections
A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1
This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART.
- Trial name
- CROWN (NCT06694805)
- Testing
- CAB LA + RPV LA, Oral ART
- Where
- 85 sites in United States, Argentina and 6 more
- Volunteers
- 326 people
- Sponsor
- ViiV Healthcare
HIV Infections
The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors
The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to…
- Trial name
- NCT00002418
- Testing
- Emivirine, Hydroxyurea, Nevirapine
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- Bristol-Myers Squibb
HIV-I, Human Immunodeficiency Virus Type 1
Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)
This study will evaluate whether oral islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection.
- Conditions
- HIV-I, Human Immunodeficiency Virus Type 1, Prophylaxis
- Trial name
- Impower-022 (NCT04644029)
- Testing
- Islatravir, FTC/TDF
- Where
- 24 sites in United States, South Africa and 1 more
- Volunteers
- 730 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
The primary objective of this study is to assess the efficacy of switching to tenofovir disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining virologic suppression in HIV-1 infected children.
- Trial name
- NCT00528957
- Testing
- Tenofovir DF, Zidovudine, Stavudine
- Where
- 9 sites in United States, Panama and 1 more
- Volunteers
- 97 people
- Sponsor
- Gilead Sciences
HIV Infection
Single DermaVir Immunization in HIV-1 Infected Patients on HAART
DermaVir is a plasmid DNA-containing synthetic nanomedicine. It is administered topically with DermaPrep to target Langerhans cells.
- Trial name
- GIHU004 (NCT00712530)
- Testing
- DermaVir, HAART
- Where
- Hungary
- Volunteers
- 9 people
- Sponsor
- Genetic Immunity
Hepatitis C Virus Infection
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.
- Trial name
- ASTRAL-5 (NCT02480712)
- Testing
- SOF/VEL
- Where
- 15 sites in United States
- Volunteers
- 107 people
- Sponsor
- Gilead Sciences
Infection, Human Immunodeficiency Virus, HIV Infections
A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)
This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine…
- Trial name
- NCT01910402
- Testing
- Dolutegravir/abacavir/lamivudine FDC, Atazanavir, Ritonavir
- Where
- 90 sites in United States, Argentina and 11 more
- Volunteers
- 499 people
- Sponsor
- ViiV Healthcare
HIV Infections
BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection
This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating…
- Trial name
- NCT00337701
- Testing
- enfuvirtide [Fuzeon]
- Where
- 44 sites in United States, Puerto Rico
- Volunteers
- 326 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet With Viread® Tablet
The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers.
- Trial name
- NCT02589457
- Testing
- CKD-390, Viread® tablet
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Chong Kun Dang Pharmaceutical
HIV Infections
A Comparison of 141W94 and Indinavir in HIV-Infected Patients
The purpose of this study is to see if 141W94 is as safe and effective as indinavir when used with nucleoside reverse transcriptase inhibitors (NRTIs) for 48 weeks.
- Trial name
- NCT00002202
- Testing
- Indinavir sulfate, Amprenavir
- Where
- 24 sites in United States
- Volunteers
- 460 people
- Sponsor
- Glaxo Wellcome
AIDS
Evaluation on Seropositive Patients of a Synthetic Vaccine Targeting the HIV Tat Protein
Tat Oyi vaccination on seropositive patients could help their immune system to recognize and neutralize Tat. The neutralization of extra cellular Tat should help the cellular immune response to eliminate HIV-1 infected cells.
- Trial name
- EVATAT (NCT01793818)
- Testing
- Tat Oyi
- Where
- France
- Volunteers
- 50 people
- Sponsor
- BIOSANTECH
Human Immunodeficiency Virus Type 1 (HIV-1), HIV Infections
Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants
This study assesses the effects of voriconazole, 200 mg, administered twice daily (BID), on the steady-state pharmacokinetics of atazanavir administered as atazanavir/ritonavir, 300/100 mg once daily (QD), in healthy participants…
- Trial name
- NCT00833482
- Testing
- Voriconazole, Atazanavir, Ritonavir
- Where
- 2 sites in United States, Netherlands
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Human Immunodeficiency Virus (HIV) Infections
A Study of Islatravir (MK-8591) in Trans and Gender Diverse Participants (MK-8591-035)
The primary objective of this study is to evaluate the safety and tolerability of Islatravir (ISL) in trans and gender diverse (TGD) participants who are receiving gender-affirming hormone therapy (GAHT) and are at low-risk for…
- Trial name
- NCT05130086
- Testing
- Islatravir
- Volunteers
- healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1
PEPI-TiDP23-C103: First-in-Human Study to Examine the Safety, Tolerability, and Plasma Pharmacokinetics of Increasing Single and Repeated Oral Doses of TMC558445 and of a Combined Single Day Dosing of Oral TMC558445 and Oral TMC310911 and Also Oral Darunavir
The purpose of the study is to determine the safety, tolerability and plasma pharmacokinetics (pk) (i.e., the levels of TMC558445 circulating in your blood over time) of increasing single oral doses of TMC558445 and of multiple…
- Trial name
- NCT00838760
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Infection, Human Immunodeficiency Virus I
A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96.
- Trial name
- SPRING-2 (NCT01227824)
- Testing
- GSK1349572 (dolutegravir), raltegravir, ABC/3TC
- Where
- 101 sites in United States, Australia and 7 more
- Volunteers
- 828 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
This study will look at whether emtricitabine is as safe and effective as abacavir (ABC) when taken with stavudine (d4T) and efavirenz (EFV) in patients who have never taken anti-HIV drugs.
- Trial name
- NCT00002362
- Testing
- Abacavir sulfate, Efavirenz, Emtricitabine
- Where
- 10 sites in United States
- Sponsor
- Triangle Pharmaceuticals