Clinical trials: Antiretroviral Therapy
HIV, HIV Infections
Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
The primary objective of this study is to evaluate the efficacy of tenofovir alafenamide (TAF) versus placebo, each administered with the existing, failing antiretroviral (ARV) regimen.
- Conditions
- HIV, HIV Infections, Acquired Immunodeficiency Syndrome
- Trial name
- NCT01967940
- Testing
- TAF, E/C/F/TAF, Current failing ARV regimen
- Where
- 15 sites in United States, Dominican Republic and 3 more
- Volunteers
- 55 people
- Sponsor
- Gilead Sciences
HIV-1 Infections
Observational Data Analysis in EuroSIDA (MK-0518-058)
The main objective of the study is to monitor health outcomes associated with antiretroviral drugs in a population of HIV-infected patients.
- Trial name
- NCT01078233
- Volunteers
- 6,617 people
- 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
HIV Infections
The Safety and Effectiveness of HBY 097 Used With or Without AZT in HIV-Infected Patients Who Have Mild or No Symptoms
To obtain preliminary information on the safety, tolerability, and antiretroviral activity of HBY 097 alone or in combination with zidovudine ( AZT ) versus AZT alone. PER 1/19/96 AMENDMENT: AZT monotherapy arm was eliminated.
- Trial name
- NCT00002357
- Testing
- HBY 097, Zidovudine
- Where
- 6 sites in United States
- Volunteers
- 144 people
- Sponsor
- Hoechst Marion Roussel
Healthy
A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs
The study purpose is to evaluate the potential for a pharmacokinetic drug-drug interaction, safety and tolerability when Narlaprevir, Ritonavir (used as a metabolic inhibitor) and Tenofovir disoproxil fumarate (part 1) and…
- Trial name
- NCT03537404
- Testing
- Narlaprevir, Ritonavir, Tenofovir Disoproxil Fumarate
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- R-Pharm
HIV Infections
A Phase 1 Safety and Immunogenicity Study of the Epitope Based DNA Vaccine (EP HIV-1090) in HIV-1 Infected Individuals Receiving Antiretroviral Therapy (ART)
The use of a Bioject 2000 needle free injection device (NFID) and a compressed immunization schedule will be safely tolerated and will augment the immunogenicity of the HIV-1 CTL epitope DNA vaccine (EP1090) in HIV-1 infected…
- Trial name
- EP1090 (NCT00532974)
- Testing
- EP1090
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Epimmune
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
Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.
To determine safety and efficacy of ACH-126,443 on the treatment of adults with HIV infection who have modestly detectable viral load while on stable triple combination antiretroviral therapy including 3TC.
- Trial name
- NCT00040157
- Testing
- ACH126-443 (Beta-L-Fd4C)
- Where
- 13 sites in United States
- Volunteers
- 60 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
HIV Infections
Bone Mineral Density in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Adult Subjects Switching From a Tenofovir Regimen to a Dolutegravir Plus Rilpivirine Regimen
The purpose of this study is to evaluate any change from baseline in bone mineral density (BMD) in subjects following the switch from a triple antiretroviral therapy (ART) regimen containing Tenofovir disoproxil fumarate (TDF) to…
- Trial name
- NCT02478632
- Testing
- Subjects do not receive study medication in this study 202094
- Where
- 32 sites in United States, Argentina and 4 more
- Volunteers
- 102 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
The purpose of this study is to compare the safety and effectiveness of emtricitabine and stavudine when given with didanosine plus efavirenz to HIV-infected patients.
- Trial name
- NCT00006208
- Testing
- Efavirenz, Emtricitabine, Stavudine
- Where
- 63 sites in United States, Argentina and 4 more
- Sponsor
- Triangle Pharmaceuticals
HIV Infections
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection.
- Trial name
- NCT07202546
- Testing
- VH4524184, Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets, Dolutegravir / Lamivudine (DTG/3TC)
- Where
- 123 sites in United States, Argentina and 12 more
- Volunteers
- 186 people
- Sponsor
- ViiV Healthcare
Human Immunodeficiency Virus (HIV) Infection
Safety, Reactogenicity and Immunogenicity of HB-502 and HB-501 Versus Placebo in People With HIV on Suppressive ART
This is a study of HB-502 and HB-501 alternating 2-vector therapy in people living with human immunodeficiency virus (HIV) who are taking antiretroviral treatment (ART).
- Trial name
- NCT06430905
- Testing
- HB-502 and HB-501 alternating 2-vector therapy Dose Level 1, HB-502 and HB-501 alternating 2-vector therapy Dose Level 2
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Hookipa Biotech GmbH
HIV, HIV Infections
Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir…
- Trial name
- NCT01797445
- Testing
- E/C/F/TAF, E/C/F/TDF
- Where
- 117 sites in United States, Canada and 9 more
- Volunteers
- 872 people
- Sponsor
- Gilead Sciences
HIV Infections
Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
The objectives of this study are to explore the metabolic toxicities associated with lopinavir/ritonavir (LPV/r) plus saquinavir mesylate (INV) versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the overall…
- Trial name
- NCT00043953
- Testing
- Lopinavir/ritonavir, Saquinavir mesylate, Lamivudine/zidovudine
- Where
- 11 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Abbott
HIV Infections
ONCE - Only Nocturnal Combination Evaluation of Antiretroviral-Experienced HIV 1 Infected Subjects Switching to Atripla
A single tablet regimen (STR) of efavirenz, emtricitabine and tenofovir disoproxil fumarate (tenofovir DF) is the first complete HAART that is offered as one tablet once a day.
- Trial name
- ONCE (NCT00615745)
- Testing
- Atripla (ATR) consisting of EFV 600 mg/FTC 200 mg/TDF 300 mg
- Where
- United Kingdom
- Volunteers
- 115 people
- Sponsor
- Gilead Sciences
HIV Infections, Fanconi Syndrome
Fanconi Syndrome Due to ARVs in HIV-Infected Persons
Cross-sectional cohort study of participants with HIV with or without protocol-defined Fanconi syndrome (confirmed creatinine clearance [CLcr] decline and evidence of proximal tubulopathy).
- Conditions
- HIV Infections, Fanconi Syndrome, Kidney Disease, Renal Impairment
- Trial name
- NCT00499187
- Testing
- Blood Draws
- Where
- 13 sites in United States, Canada
- Volunteers
- 56 people
- Sponsor
- Gilead Sciences
HIV-1
TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents
The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.
- Trial name
- NCT00665847
- Testing
- Etravirine (TMC125), Optimized background regimen (OBR)
- Where
- 42 sites in United States, Argentina and 11 more
- Volunteers
- 103 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infection
A Comparison of Body Fat Distribution in HIV-1 Infected Patients Receiving, Since the Beginning and for at Least Two Years, an Antiretroviral Therapy Based on Efavirenz or Lopinavir/Ritonavir Combined With Tenofovir + Emtricitabine or Lamivudine
The purpose of this study is to compare the body fat distribution in Human Immunodeficiency Virus-1 (HIV-1) infected patients receiving, since the beginning and for at least two years, an antiretroviral therapy based on efavirenz…
- Trial name
- LYNX (NCT01159743)
- Where
- 26 sites in Spain
- Volunteers
- 346 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Infection, Human Immunodeficiency Virus
Dose-finding Study of GSK2248761 in Antiretroviral Therapy-Naive Subjects (SIGNET)
This 96 week, Phase 2b study in 150 HIV-1 infected antiretroviral (ART) naive adult subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg once daily with a control arm of open-label…
- Trial name
- SIGNET (NCT01231555)
- Testing
- GSK2248761 100 mg once daily, GSK2248761 200 mg once daily, Efavirenz 600 mg once daily
- Where
- 12 sites in France, Germany and 1 more
- Volunteers
- 23 people
- Sponsor
- ViiV Healthcare
HIV, HIV Infections
Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir…
- Trial name
- NCT01780506
- Testing
- E/C/F/TAF, E/C/F/TDF
- Where
- 117 sites in United States, Australia and 10 more
- Volunteers
- 872 people
- Sponsor
- Gilead Sciences