Clinical trials: HIV-1
HIV Infections
Evaluating Safety and Immune Response to the HIV-1 CH505 Transmitted/Founder gp120 Adjuvanted With GLA-SE in Healthy, HIV-exposed Uninfected Infants
This study evaluated the safety and immune response in healthy HIV-exposed and uninfected infants to the protein vaccine, CH505TF gp120, adjuvanted with GLA-SE.
- Trial name
- HVTN 135 (NCT04607408)
- Testing
- CH505TF gp120, GLA-SE adjuvant
- Where
- South Africa
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network
HIV Infections
Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults
Primary purpose of this study is to compare the efficacy and safety of two different nevirapine (Viramune) dosing regimens (once daily (QD) and twice daily (BID) application) and of atazanavir/ritonavir (Reyataz/Norvir), all on…
- Trial name
- NCT00389207
- Testing
- nevirapine bid, nevirapine qd, atazanavir
- Where
- 68 sites in Argentina, Germany and 8 more
- Volunteers
- 576 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy
The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy.
- Trial name
- ESPRIT (NCT00004978)
- Testing
- Recombinant interleukin-2 (rIL-2)
- Where
- 248 sites in United States, Argentina and 23 more
- Volunteers
- 4,150 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Acquired Immunodeficiency Syndrome, HIV Infections
D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults
This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir…
- Trial name
- NCT01565850
- Testing
- D/C/F/TAF, DRV, COBI
- Where
- 44 sites in United States, Puerto Rico
- Volunteers
- 153 people
- Sponsor
- Gilead Sciences
HIV-1-infection, Hepatitis B
B/F/TAF Switch Study for HIV-HBV Coinfection
The primary objective of this study is to evaluate the efficacy and safety of fixed dose combination (FDC) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in adults coinfected with both HIV-1 and hepatitis B.
- Trial name
- BEST-HBV (NCT03797014)
- Testing
- B/F/TAF
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- University of Maryland, Baltimore
Neuropathy
Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.
- Trial name
- NCT01049217
- Testing
- pregabalin
- Where
- 63 sites in United States, Colombia and 7 more
- Volunteers
- 377 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Human Immunodeficiency Virus (HIV)
Romidepsin Plus 3BNC117 Phase 2a Study
The aim of this protocol is to evaluate the effects of romidepsin plus 3BNC117 or romidepsin alone on delaying or preventing viral rebound in ART-treated HIV-1-infected individuals during an analytical interruption of ART.
- Trial name
- ROADMAP (NCT02850016)
- Testing
- 3BNC117, Romidepsin
- Where
- 3 sites in United States, Denmark and 1 more
- Volunteers
- 48 people
- Sponsor
- Rockefeller University
HIV-1
Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)
To establish a new treatment option for treatment-naïve participants with HIV-1, the efficacy and safety of doravirine will be determined relative to a protease inhibitor (PI).
- Trial name
- DRIVE-FORWARD (NCT02275780)
- Testing
- Doravirine, Darunavir, Ritonavir
- Volunteers
- 769 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1 Infection
Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV
The primary objective of this study is to evaluate the efficacy of oral weekly islatravir (ISL) in combination with lenacapavir (LEN) in virologically suppressed people with HIV (PWH) at Week 24.
- Trial name
- NCT05052996
- Testing
- ISL, LEN, B/F/TAF
- Where
- 44 sites in United States
- Volunteers
- 142 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents
The purpose of this study is to evaluate pharmacokinetics (what body does to medication), safety, tolerability, and efficacy (effectiveness) of darunavir with low-dose ritonavir (DRV/rtv) administered once daily, in combination…
- Trial name
- DIONE (NCT00915655)
- Testing
- darunavir, ritonavir, zidovudine
- Where
- 9 sites in United States, France and 4 more
- Volunteers
- 12 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Human Immunodeficiency Virus
Prospective Observational Epidemiologic Study of Maraviroc's Safety
The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.
- Trial name
- POEM (NCT00665561)
- Testing
- Maraviroc along with an optimized background antiretroviral drug regimen, Optimized background antiretroviral drug regimen without maraviroc
- Where
- 269 sites in United States, Belgium and 9 more
- Volunteers
- 2,500 people
- Sponsor
- ViiV Healthcare
HIV, Impaired Cognition
Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa
The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period.
- Trial name
- CogUK (NCT01367236)
- Testing
- standard care, novel treatment
- Where
- 6 sites in United Kingdom
- Volunteers
- 60 people
- Sponsor
- Imperial College London
AIDS Dementia Complex, HIV-1-Associated Cognitive Motor Complex
Effect of Cenicriviroc on HIV Neurocognitive Impairment
The study hypothesis is that cenicriviroc will improve cognition in HIV infected individuals with cognitive impairment. The investigators will study the effect of cenicriviroc on cognition in 24 subjects over a 24 week period.
- Conditions
- AIDS Dementia Complex, HIV-1-Associated Cognitive Motor Complex, Human Immunodeficiency Virus
- Trial name
- NCT02128828
- Testing
- cenicriviroc
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Hawaii
HIV-1 Infection
Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]
This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + ulonivirine based on review of the accumulated safety data, in adult participants with human immunodeficiency…
- Trial name
- NCT04564547
- Testing
- Islatravir, Ulonivirine, BIC/FTC/TAF
- Where
- 23 sites in United States, France and 1 more
- Volunteers
- 161 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01)
The researchers are involved in a phase II, randomized, two-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with Truvada to a 5-drug multi-class regimen including…
- Trial name
- NCT00525733
- Testing
- darunavir 800 mg, FTC 200 mg/TDF 300mg, Maraviroc
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Rockefeller University
Human Immunodeficiency Virus
Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults
The purpose of the study is to assess: 1 safety and tolerability of adenovirus serotype 26 (Ad26) prime and Modified Vaccinia Ankara (MVA) boost versus placebo in participants on suppressive antiretroviral therapy (ART) that was…
- Trial name
- NCT02919306
- Testing
- Ad26.Mos.HIV, MVA-Mosaic
- Where
- Thailand
- Volunteers
- 27 people
- Sponsor
- Janssen Vaccines & Prevention B.V.
HIV Infection, Tuberculosis
Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV
There is a rapidly-growing need to identify evidence-based, safe, and effective co-treatment regimens for HIV-related tuberculosis (TB) among patients who require protease inhibitor (PI)-based antiretroviral therapy (ART).
- Trial name
- NCT01601626
- Testing
- Standard-dose Lopinavir/Ritonavir, Double-dose Lopinavir/Ritonavir, Raltegravir
- Where
- 9 sites in Brazil, Haiti and 3 more
- Volunteers
- 71 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Healthy
A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals
The purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection…
- Trial name
- MOSAICO (NCT03964415)
- Testing
- Ad26.Mos4.HIV, Clade C and Mosaic gp140 HIV bivalent vaccine
- Where
- 53 sites in United States, Argentina and 7 more
- Volunteers
- 3,900 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
HIV Infection
A Safety and Immunogenicity Trial of IHV01
This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized, placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult volunteers (Human Immunodeficiency Virus-1…
- Trial name
- FLSC-001 (NCT02756208)
- Testing
- 300 ug FLSC vaccine, 150 ug FLSC vaccine, 75 ug FLSC vaccine
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore