Clinical trials: Human Immunodeficiency Virus Type 1
Anti-Retroviral Agents, Efavirenz
Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression
According to the Thai National Guidelines for Treatment of HIV/AIDS 2014, the recommended first line ART regimen was 2 NRTIs backbone, TDF and FTC; plus 1 NNRTI, EFV, with RPV as an alternative one.
- Conditions
- Anti-Retroviral Agents, Efavirenz, HIV-1-infection, Sustained Virologic Response
- Trial name
- STEREOS (NCT03251690)
- Testing
- Tenofovir/Emtricitabine/Rilpivirine, Tenofovir/Emtricitabine/Efavirenz
- Volunteers
- 246 people
- Sponsor
- Mahidol University
HIV-1-infection
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV
The goal of this clinical study is to learn more about the study drug, Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), safety, tolerability, and pharmacokinetics (how B/F/TAF is absorbed, modified, distributed, and…
- Trial name
- NCT07055451
- Testing
- B/F/TAF
- Where
- 7 sites in United States, South Africa
- Volunteers
- 16 people
- Sponsor
- Gilead Sciences
HIV-1-infection
Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
The primary objective of this study is to evaluate HIV-1 RNA suppression, defined as HIV-1 RNA < 50 copies/mL, at 12 months after initiating or switching to bictegravir/ emtricitabine/tenofovir alafenamide (B/F/TAF).
- Trial name
- BIC-STaR (NCT04009057)
- Testing
- B/F/TAF
- Where
- 5 sites in Israel
- Volunteers
- 143 people
- Sponsor
- Gilead Sciences
HIV
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) in infants born to mothers living with HIV-1.
- Trial name
- NCT05406583
- Testing
- Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life), Dolutegravir 5 mg Dispersible Tablets (single doses), Dolutegravir 5 mg Dispersible Tablets (chronic dose)
- Where
- 15 sites in United States, South Africa and 1 more
- Volunteers
- 96 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients
To compare the effectiveness (efficacy, safety \& tolerability) of a Single Tablet Regimen of efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured by the proportion of patients who maintain…
- Trial name
- NCT00365612
- Testing
- Efavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)
- Where
- 56 sites in United States, Puerto Rico
- Volunteers
- 300 people
- Sponsor
- Gilead Sciences
HIV-1-infection
ANCHORS Study: UH2 Project
According to the National HIV/AIDS Strategy, men who have sex with men (MSM), young adults, Black and Latino men and people in the Southern U.S.
- Trial name
- ANCHORS (NCT03360422)
- Testing
- Survey, Focus Group, Usability study
- Where
- United States
- Volunteers
- 673 people, healthy volunteers welcome
- Sponsor
- University of Florida
HIV Infections
Study Using CABENUVA™ for the Treatment of Human Immunodeficiency Virus (HIV)-1, Administered in Infusion Centers (IC) or Alternate Sites of Administration (ASA) in the United States (U.S.)
GLACIER (Giving Long Acting CABENUVA in an Infusion center/ASA) is an interventional study examining the administration of CABENUVA (Cabotegravir long acting [LA] plus Rilpivirine LA) intramuscular (IM) in infusion centers/ASAs…
- Trial name
- GLACIER (NCT04982445)
- Testing
- CABENUVA
- Where
- 15 sites in United States
- Volunteers
- 44 people
- Sponsor
- ViiV Healthcare
HIV Infections
An Investigational Combination Vaccine Given to People Who Are Not Infected With HIV
The purpose of this study is to see if the investigational vaccines NefTat and gp120w61d are safe and tolerable in humans and to see how the immune system responds to the vaccines.
- Trial name
- NCT00027365
- Testing
- Combination Vaccine (NefTat and gp120W61D) Formulated with AS02A, NefTat, AS02A Adjuvant
- Where
- 15 sites in United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
A Phase 4 study is to characterize the profile of low bone mineral density (BMD) in ≥ 50 year old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate (TDF)-based regimen
- Trial name
- NCT01850212
- Where
- 73 sites in Austria, Belgium and 11 more
- Volunteers
- 476 people
- Sponsor
- Gilead Sciences
HIV Infections
A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1
The primary purpose of this study is to assess the antiviral activity of VH3739937 in Human Immunodeficiency Virus Type-1 (HIV-1) infected treatment naive (TN) participants during monotherapy.
- Trial name
- NCT06061081
- Testing
- VH3739937
- Where
- 18 sites in United States, Argentina and 4 more
- Volunteers
- 21 people
- Sponsor
- ViiV Healthcare
HPV Vaccine, HPV Infection
Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
Longitudinal observational cohort study and extension of the MISP ID: 38406 'immunogenicity and safety of quadrivalent human papillomavirus vaccine in HIV-infected pre-adolescent girls and boys in Kenya'.
- Conditions
- HPV Vaccine, HPV Infection, HIV-1-infection
- Trial name
- NCT04711265
- Testing
- Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine
- Where
- Kenya
- Volunteers
- 176 people
- Sponsor
- Kenya Medical Research Institute
HIV INFECTION
Evaluation of a Dose Reduction of Darunavir (400 mg/d) in Virologically Suppressed HIV-1 Patients
Phase II trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse…
- Trial name
- DARULIGHT (NCT02384967)
- Testing
- Darunavir
- Where
- France
- Volunteers
- 100 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infection, HIV
#AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-implementation Trial.
The #aware.hiv Europe study is a real-world, multicenter, stepped-wedge cluster randomized, effectiveness-implementation trial designed to evaluate whether the introduction of dedicated HIV teams in hospitals can improve HIV…
- Conditions
- HIV Infection, HIV, Stigma, Education
- Trial name
- #aware hiv (NCT06900829)
- Testing
- HIV team implementation
- Where
- 28 sites in Belgium, France and 8 more
- Volunteers
- 5,200 people, healthy volunteers welcome
- Sponsor
- Casper Rokx
HIV Infections
Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.
- Trial name
- NCT02256631
- Testing
- VRC01, VRC01LS, VRC07-523LS
- Where
- 14 sites in United States, Puerto Rico and 2 more
- Volunteers
- 83 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1-infection, HIV Infections
A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA
The purpose of this study is to evaluate the efficacy and safety of CABENUVA (Long-acting Cabotegravir Plus Long-acting Rilpivirine) in patients with HIV infection and severe renal impairment.
- Conditions
- HIV-1-infection, HIV Infections, HIV I Infection
- Trial name
- CAPRI (NCT05601128)
- Testing
- CAB + RPV
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Acquired Immune Deficiency Syndrome, Human Immunodeficiency Virus
Dose Optimisation of Stavudine for the Treatment of HIV Infection
The purpose of this study is to demonstrate whether low dose stavudine (d4T) is non-inferior (in terms of both viral suppression and toxicity) to tenofovir (TDF) after 2 years of HIV treatment.
- Trial name
- D4T (NCT02670772)
- Testing
- Stavudine, Tenofovir Disoproxil Fumarate
- Where
- 3 sites in India, South Africa and 1 more
- Volunteers
- 1,077 people, healthy volunteers welcome
- Sponsor
- Willem Daniel Francois Venter
HIV Infections, H1N1 Influenza Virus
Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women
Both pregnant women and people infected with HIV are at increased risk of viral infection, including influenza infection. Pregnant women infected with HIV may be at particular risk of infection from the new H1N1 influenza virus.
- Trial name
- NCT00992017
- Testing
- Influenza A (H1N1) monovalent vaccine
- Where
- 31 sites in United States, Puerto Rico
- Volunteers
- 130 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived HIV-1 Recombinant Envelope Glycoprotein (gp160)
To determine the safety of vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) in human volunteers; to evaluate the immunogenicity of this preparation in human volunteers.
- Trial name
- NCT00000968
- Testing
- gp160 Vaccine (Immuno-AG)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Human Immunodeficiency Virus
Impact of Pre-ART Blood CD4+ T Cell Level on the Rectal Reservoir in Long-term HIV-1 Treated Men
Although combined antiretroviral therapy (cART) has dramatically improved quality of life and lifespan of HIV infected individuals, it still fails to eliminate viral reservoirs.
- Trial name
- VIRECT (NCT02526940)
- Testing
- rectal biopsies, Blood samples
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
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