Clinical trials: HIV I Infection
HIV I Infection
Safety and Efficacy of Romidepsin and the Therapeutic Vaccine Vacc-4x for Reduction of the Latent HIV-1 Reservoir
The REDUC trial's objective is to address one of the core issues with the treatment of HIV, which is that some HIV infected cells hide in so-called latent reservoirs.
- Trial name
- REDUC (NCT02092116)
- Testing
- Romidepsin, Vacc-4x, rhuGM-CSF
- Where
- Denmark
- Volunteers
- 26 people
- Sponsor
- Bionor Immuno AS
Hepatitis C Infection With HIV Co-Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV)…
- Trial name
- NCT02457611
- Testing
- LDV/SOF
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR
The purpose of this Phase 2b study was to evaluate the efficacy and safety of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR, after switching from the efavirenz (EFV)/FTC/TDF STR at baseline, in…
- Trial name
- NCT01286740
- Testing
- FTC/RPV/TDF
- Where
- 18 sites in United States
- Volunteers
- 50 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)
This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve…
- Trial name
- NCT04233879
- Testing
- DOR/ISL, BIC/FTC/TAF
- Where
- 95 sites in United States, Argentina and 11 more
- Volunteers
- 599 people
- Sponsor
- Merck Sharp & Dohme LLC
Infection, Human Immunodeficiency Virus
Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection
This 48 week, phase 2b study in 150 HIV-1 infected antiretroviral therapy experienced 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…
- Trial name
- SONNET (NCT01199731)
- Testing
- GSK2248761 100 mg once daily, GSK2248761 200 mg once daily, Etravirine
- Where
- 41 sites in United States, Belgium and 3 more
- Volunteers
- 30 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection
Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults
The primary objective of this study is to evaluate the efficacy of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) relative to continuing on a baseline regimen…
- Trial name
- NCT02605954
- Testing
- E/C/F/TAF, ABC/3TC, Third Antiretroviral Agent
- Where
- 49 sites in United States, France and 4 more
- Volunteers
- 275 people
- Sponsor
- Gilead Sciences
Infection, Human Immunodeficiency Virus
A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)
This study is designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC)…
- Trial name
- ASSURE (NCT01102972)
- Testing
- Reyataz + Norvir + Truvada, Reyataz + Epzicom
- Where
- 46 sites in United States, Puerto Rico
- Volunteers
- 297 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus, HIV Infections
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years…
- Trial name
- NCT00071760
- Testing
- GW433908, ritonavir
- Where
- 15 sites in United States, Argentina and 5 more
- Volunteers
- 59 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection
MK-8583 Single Dose Study in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8583-002)
This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-retroviral therapy (ART) activity of the tenofovir prodrug, MK-8583 monotherapy in ART-naïve, HIV-1 infected participants.
- Trial name
- NCT03552536
- Testing
- MK-8583
- Where
- Germany
- Volunteers
- 5 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1 Infection
Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed
The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine…
- Trial name
- NCT02603120
- Testing
- ABC/DTG/3TC, B/F/TAF
- Where
- 94 sites in United States, Australia and 8 more
- Volunteers
- 567 people
- Sponsor
- Gilead Sciences
Infection, Human Immunodeficiency Virus
A Study of the Pharmacokinetics and Antiviral Activity of Dolutegravir in the Central Nervous System in HIV-1 Infected ART-naive Subjects
ING116070 is a Phase IIIb single-arm, open-label, multicenter study. The study will be conducted in approximately 14 HIV-1 infected antiretroviral therapy (ART)-naïve subjects.
- Trial name
- NCT01499199
- Testing
- Dolutegravir
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- ViiV Healthcare
HIV-1-infection
Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters
The primary objective of this study is to evaluate the steady state PK of bictegravir (BIC) and confirm the dose of BIC/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) in HIV-1 infected…
- Trial name
- NCT03960645
- Testing
- B/F/TAF
- Where
- 8 sites in United States, Dominican Republic and 1 more
- Volunteers
- 62 people
- Sponsor
- Gilead Sciences
HIV, Human Immunodeficiency Virus
Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection
This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy.
- Trial name
- NCT02175680
- Testing
- PRO 140, Historical data
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- CytoDyn, Inc.
Infection, Human Immunodeficiency Virus
Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects
This study will be conducted in approximately 468 HIV-1 infected antiretroviral therapy (ART)-naïve subjects. Subjects will be randomized 1:1 to receive dolutegravir (DTG) 50 mg once daily (approximately 234 subjects) or…
- Trial name
- FLAMINGO (NCT01449929)
- Testing
- dolutegravir 50 mg OAD, darunavir 800mg OAD, ritonavir 100mg OAD
- Where
- 66 sites in United States, France and 7 more
- Volunteers
- 488 people
- Sponsor
- ViiV Healthcare
HIV Infections
Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers
The objective of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.
- Trial name
- NCT01374802
- Testing
- Darunavir, Ritonavir, BI 201335
- Where
- Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
HIV-1 Infection, Neuropathic Pain
Pregabalin Trial In HIV Neuropathic Pain
This study examines the safety of pregabalin over a 6 month period in patients with neuropathic pain associated with HIV infection as an extension of another trial that tests the efficacy of pregabalin.
- Trial name
- NCT01145417
- Testing
- pregabalin (Lyrica)
- Where
- 29 sites in United States, Colombia and 5 more
- Volunteers
- 217 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
HIV-1 Infection
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
The primary objectives of this study are: Part A: To evaluate the short-term antiviral activity of lenacapavir (formerly GS-6207) with respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day…
- Trial name
- NCT03739866
- Testing
- Lenacapavir, B/F/TAF, TAF
- Where
- 12 sites in United States
- Volunteers
- 53 people
- Sponsor
- Gilead Sciences
HIV -1 Infection, HIV Infections
Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection
The purpose of this study is: 1. To assess the antiviral activity of PRO 140 2. To assess the safety and tolerability of PRO 140 3. To generate additional PK, PD and safety data of PRO 140
- Trial name
- NCT00642707
- Testing
- PRO 140 (humanized monoclonal antibody to CCR5)
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- CytoDyn, Inc.
CCR5-tropic HIV-1 Infection
Safety And Efficacy Of Maraviroc In Patients For HIV Patients (Regulatory Post Marketing Commitment Plan)
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Trial name
- NCT00864474
- Testing
- CELSENTRI® Tablets
- Volunteers
- 68 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.
This single arm study will assess the pharmacokinetics, safety and activity of saquinavir (Invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination with ritonavir, in HIV-1 infected infants and…
- Trial name
- NCT00623597
- Testing
- ritonavir, saquinavir [Invirase]
- Where
- 10 sites in Argentina, Spain and 1 more
- Volunteers
- 18 people
- Sponsor
- Hoffmann-La Roche