Clinical trials: HIV1 Infection
HIV-1 Infection
Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the incidence of adverse drug reactions in this…
- Trial name
- NCT00823966
- Testing
- Rescriptor
- Volunteers
- 3 people
- Sponsor
- Pfizer
HIV Infections
Antiviral Activity and Safety of Mifepristone at 2 Doses in HIV-1 Infected Subjects
The objective of the study is to determine whether mifepristone (VGX-410) has anti-HIV-1 activity at doses of either 300 mg or 600 mg per day after oral administration for 14 days at each dose level.
- Trial name
- NCT00352911
- Testing
- VGX-410 (Mifepristone)
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- VGX Pharmaceuticals, LLC
HIV Infections
Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy
HIV infected pregnant women may take single-dose nevirapine (SD NVP) prior to giving birth to prevent mother-to-child transmission (MTCT) of HIV.
- Trial name
- NCT00099632
- Testing
- Emtricitabine/Tenofovir Disoproxil Fumarate, Lamivudine/Zidovudine, Lopinavir/Ritonavir
- Where
- 8 sites in Haiti, India and 4 more
- Volunteers
- 484 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Comparative Efficacy and Safety Study of Dolutegravir and Lopinavir/Ritonavir in Second-line Treatment
For treatment of human immunodeficiency virus type 1(HIV-1), publicly funded programmes tend to follow World Health Organization (WHO) guidelines to use a non-nucleoside reverse transcriptase inhibitor (NNRTI) combined with two…
- Trial name
- NCT02227238
- Testing
- DTG, LPV/RTV, Two NRTIs
- Where
- 59 sites in Argentina, Brazil and 11 more
- Volunteers
- 627 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection
Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral…
- Trial name
- NCT02397694
- Testing
- BIC, F/TAF, DTG
- Where
- 21 sites in United States
- Volunteers
- 98 people
- Sponsor
- Gilead Sciences
HIV, HIV Infections
Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and…
- Trial name
- NCT01818596
- Testing
- E/C/F/TAF
- Where
- 70 sites in United States, Australia and 7 more
- Volunteers
- 252 people
- Sponsor
- Gilead Sciences
HIV-1
A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1
The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.
- Trial name
- NCT00824369
- Testing
- No drug will be administered
- Where
- 27 sites in United States, Argentina and 10 more
- Volunteers
- 52 people
- Sponsor
- Pfizer
HIV-1 Infection
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis
The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1)…
- Trial name
- NCT02600819
- Testing
- E/C/F/TAF, B/F/TAF
- Where
- 26 sites in United States, Austria and 2 more
- Volunteers
- 55 people
- Sponsor
- Gilead Sciences
Human Immunodeficiency Virus Type 1
Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants
The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF)…
- Trial name
- NCT02269917
- Testing
- D/C/F/TAF, Boosted Protease Inhibitor (bPI), FTC/TDF
- Where
- 79 sites in United States, Belgium and 8 more
- Volunteers
- 1,149 people
- Sponsor
- Janssen R&D Ireland
HIV-1 Infection, Tuberculosis
PK Study of Rifampicin Interactions With DMPA and Efavirenz in TB
This study was done to evaluate the effect of HIV and TB treatment on a commonly used birth control method. It enrolled women who were infected with HIV and TB and were taking efavirenz (EFV; Sustiva®; an anti-HIV medication)…
- Trial name
- PRIDE-HT (NCT02412436)
- Testing
- Depot medroxyprogesterone acetate
- Where
- 5 sites in Botswana, Kenya and 2 more
- Volunteers
- 62 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV-1 Infection
Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women
The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of…
- Trial name
- NCT02652624
- Testing
- E/C/F/TAF, E/C/F/TDF, ATV
- Where
- 56 sites in United States, Dominican Republic and 4 more
- Volunteers
- 472 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults
This is a double blind, randomized, placebo-controlled, parallel design, study in which 24 HIV-infected participants with durable viral suppression will be randomly assigned to receive vaccination with MVA.tHIVconsv3 (M3)…
- Trial name
- M&M (NCT03844386)
- Testing
- MVA.tHIVconsv3, MVA.tHIVconsv4
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV
The purpose of this study is to determine if pregnancy-limited, short-term combination HIV treatment regimens -- which were used solely for the prevention of mother to child transmission of HIV and discontinued postpartum …
- Trial name
- Nearly Naive (NCT00442962)
- Testing
- Efavirenz, Emtricitabine/Tenofovir disoproxil fumarate
- Where
- 9 sites in United States, Brazil and 1 more
- Volunteers
- 54 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Acquired Immunodeficiency Syndrome, HIV Infections
Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women
The primary objective of this study is to evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus…
- Trial name
- WAVES (NCT01705574)
- Testing
- E/C/F/TDF, ATV, RTV
- Where
- 99 sites in United States, Belgium and 10 more
- Volunteers
- 583 people
- Sponsor
- Gilead Sciences
Infection, Human Immunodeficiency Virus
Phase IIa Dose-ranging Study of GSK1349572 in HIV-1 Infected Adults
GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase IIa, multicenter, randomized, parallel, double-blind, dose ranging, placebo-controlled 'proof of concept' study is to be…
- Trial name
- NCT00708110
- Testing
- GSK1349572
- Where
- 18 sites in United States
- Volunteers
- 35 people
- Sponsor
- ViiV Healthcare
HIV Infections
Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-2)
The aim of this study was to determine if virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a…
- Trial name
- NCT02422797
- Testing
- DTG 50 mg, RPV 25 mg, CAR
- Where
- 61 sites in United States, Argentina and 9 more
- Volunteers
- 518 people
- Sponsor
- ViiV Healthcare
HIV-1
A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years
The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen…
- Trial name
- NCT00799864
- Testing
- Rilpivirine, Zidovudine, Abacavir
- Where
- 17 sites in United States, India and 6 more
- Volunteers
- 54 people
- Sponsor
- Janssen Sciences Ireland UC
Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants
The primary objectives of this study are to evaluate the safety, tolerability and steady-state PK and confirm the dose of EVG/r in HIV-1 infected, antiretroviral treatment-experienced children 4 weeks to <18 years of age.
- Trial name
- NCT01923311
- Testing
- EVG, Background regimen
- Where
- 11 sites in United States, Italy and 4 more
- Volunteers
- 31 people
- Sponsor
- Gilead Sciences
HIV-1-infection, Solid Organ Transplant
Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant Patients
The aims of this study are to obtain pharmacokinetic data on interactions between dolutegravir (DTG) and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Sirolimus and Mycophenolic acid) in solid organ transplant (SOT)…
- Trial name
- NCT03360682
- Testing
- Lamivudine 300 MG, Abacavir 600 MG, Dolutegravir 50 mg
- Where
- Spain
- Volunteers
- 19 people
- Sponsor
- Fundacion Clinic per a la Recerca Biomédica
Infection, Human Immunodeficiency Virus I, HIV-1 Infection
HIV-1 Infection Study of Once a Day Versus Twice a Day Protease Inhibitor in Antiretroviral Treatment Naive Adults
This is a Phase IIIB, 48 Week, multicentre, randomized, open-label, parallel group study comparing the safety and efficacy of fosamprenavir plus ritonavir 1400mg/100mg once-daily to fosamprenavir plus ritonavir 700mg/100mg…
- Trial name
- NCT00450580
- Testing
- fosamprenavir/ritonavir
- Where
- 69 sites in Belgium, France and 7 more
- Volunteers
- 212 people
- Sponsor
- ViiV Healthcare