Clinical trials: HIV/AIDS
HIV
Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring
This prospective, randomized, single-blinded, placebo controlled trial will examine the safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate (TDF) vaginal ring when used continuously for 14 consecutive…
- Trial name
- TDF IVR-001 (NCT02006264)
- Testing
- TDF Intravaginal Ring
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Albert Einstein College of Medicine
HIV Pre-Exposure Prophylaxis
Supporting Tailored And Responsive PrEP in Rural North Carolina
This project consists of two phases to be completed over five years. Phase 1 (Aims 1 and 2) will be completed during Years 1-3 (R61).
- Trial name
- STARR-NC (NCT05984030)
- Testing
- PrEP Navigation Services, Telehealth PrEP Services Referral, HealthMpowerment Digital Health Intervention - Enhanced
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV-HCV
Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV
Chronic hepatitis C virus (HCV) infection is a major public health problem with an estimated 180 million people infected worldwide.
- Trial name
- NCT02124044
- Testing
- Asunaprevir and Daclatasvir, Asunaprevir and Daclatasvir with BMS-791325
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
Streptococcal Infections, Gram-Positive Bacterial Infections
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring.
- Conditions
- Streptococcal Infections, Gram-Positive Bacterial Infections, Bacterial Infections
- Trial name
- NCT01412801
- Testing
- Group B streptococcus vaccine
- Where
- 2 sites in Malawi, South Africa
- Volunteers
- 270 people
- Sponsor
- Novartis Vaccines
Contact Tracing
Enhancing Partner Services Among Men Who Have Sex With Men Living With HIV
Individuals will participate in a pilot randomized controlled trial (RCT) that implements and evaluates the feasibility, acceptability, and effectiveness of crowdsourced partner services (PS) or conventional PS among Chinese men…
- Trial name
- NCT04971967
- Testing
- Crowdsourced partner services intervention
- Where
- China
- Volunteers
- 121 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infection
Safety and Efficacy Study of Switching From Epzicom to Truvada
This protocol describes a prospective, randomized, open-label, multicenter study to evaluate the safety and efficacy of switching from fixed dose abacavir (ABC)/lamivudine (3TC) to fixed dose emtricitabine (FTC)/tenofovir…
- Trial name
- SWIFT (NCT00724711)
- Testing
- emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), abacavir (ABC)/lamivudine (3TC)
- Where
- 80 sites in United States, Canada and 1 more
- Volunteers
- 312 people
- Sponsor
- Gilead Sciences
Adolescent HIV Infection
Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase
Combination interventions with mHealth and Peer Navigation components will be evaluated in a randomized, stepped wedge trial among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria.
- Trial name
- iCARE (NCT04950153)
- Testing
- Peer navigation, SMS Text messaging
- Where
- 6 sites in Nigeria
- Volunteers
- 541 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Syphilis
Syphilis Response to Higher Penicillin Dosage: The 2.4 Versus 7.2 Study
Syphilis remains a significant health problem worldwide, with an estimated 10.6 million new cases per year. Due to shared transmission route and risk factors, co-infection with syphilis and Human Immunodeficiency Virus (HIV) is…
- Trial name
- NCT02611765
- Testing
- Benzathine penicillin G intramuscular 7.2 million units, Benzathine penicillin G intramuscular 2.4 million units
- Volunteers
- 64 people
- Sponsor
- Baylor College of Medicine
Distress, Depression
Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
The purpose of this study is to determine whether psilocybin-assisted group psychotherapy is a safe and feasible treatment for demoralization in long-term AIDS survivors (LTAS).
- Conditions
- Distress, Depression, Grief
- Trial name
- NCT02950467
- Testing
- Psilocybin, Modified brief Supportive Expressive Group Therapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Joshua Woolley
Sexually Transmitted Diseases, Safe Sex
P3 (Prepared, Protected, emPowered)
P3 (Prepared, Protected, emPowered) is an interactive smartphone app for HIV-uninfected YMSM and YTW that utilizes social networking and game-based mechanics as well as a comprehensive understanding of what constitutes "best…
- Conditions
- Sexually Transmitted Diseases, Safe Sex, Adherence, Medication
- Trial name
- P3 (NCT03320512)
- Testing
- P3, P3+, Control
- Where
- 9 sites in United States
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections, Mild Cognitive Impairment
Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV Supplement
In our Supplement Aim we will conduct a two-arm randomized pilot test of the adapted intervention compared to a usual care control group among 30 African American/Black women with HIV (15/arm) to assess the feasibility and…
- Trial name
- NCT04984681
- Testing
- Mindfulness, Usual Care
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Alabama at Birmingham
HIV Infections
HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) Vaccine Study
This study evaluated the safety, immunogenicity, and preliminary assessment of efficacy of a novel vaccine encoding conserved elements (CE) of the HIV-1 Gag core protein, p24Gag, as a therapeutic vaccine in HIV-1 infected persons…
- Trial name
- NCT03560258
- Testing
- p24CE1/2 pDNA vaccine, p24CE1/2 pDNA vaccine admixed with full-length p55^gag pDNA vaccine, Full-length p55^gag pDNA vaccine
- Where
- 15 sites in United States, Puerto Rico
- Volunteers
- 45 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, Renal Transplant Rejection
Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) After Renal Transplant
This is an open-label study, where participants will be switched from their current HIV medication to the study drug, BIC/F/TAF. Open-label means both the investigator and the participant will know what drug will be given.
- Trial name
- NCT04530630
- Testing
- BIC/F/TAF 50Mg-200Mg-25Mg Tablet
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Weill Medical College of Cornell University
Human Immunodeficiency Virus (HIV)
Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis
This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight weeks over a 40 week period among sexually active…
- Trial name
- TMC278LA (NCT02165202)
- Testing
- Rilpivirine
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- PATH
HIV-1 Infection
High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART
This study was done with people who were infected with HIV and needed to start treatment for their HIV disease. The purpose of this study is to see if taking vitamin D and calcium will help prevent the bone loss that sometimes…
- Trial name
- NCT01403051
- Testing
- EFV/FTC/TDF, Calcium Carbonate, Vitamin D3
- Where
- 39 sites in United States, Puerto Rico
- Volunteers
- 167 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV Infections
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir 1000mg/100mg po bid in HIV patients.
- Trial name
- NCT00435929
- Testing
- Ritonavir, saquinavir [Invirase]
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
HIV
Bone and Body Comp: A Sub Study of the SECOND-LINE Study
The use of anti HIV drugs (ART), and in particular a class of drugs known as nucleoside reverse transcriptase inhibitors (N(t)RTI), has been associated with changes in body fat and in particular loss of peripheral fat in the…
- Trial name
- NCT01513122
- Testing
- Lopinavir / ritonavir, 2-3N(t)RTI, raltegravir
- Where
- 7 sites in Argentina, India and 3 more
- Volunteers
- 210 people
- Sponsor
- Kirby Institute
Human Immunodeficiency Virus (HIV), Nonalcoholic Fatty Liver Disease (NAFLD)
Tesamorelin Effects on Liver Fat and Histology in HIV
Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV) infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of patients with HIV infection.
- Conditions
- Human Immunodeficiency Virus (HIV), Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
- Trial name
- NCT02196831
- Testing
- tesamorelin
- Where
- 2 sites in United States
- Volunteers
- 61 people
- Sponsor
- Massachusetts General Hospital
HIV Infections, Acquired Immunodeficiency Syndrome
TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients
The purpose of this study is to determine the pharmacokinetics (how the body absorbs, distributes, metabolizes and eliminates a drug) (PK) of ETR when given with ATV/rtv and 1 NRTI in treatment experienced HIV-1 infected…
- Trial name
- NCT00896051
- Testing
- Atazanavir (ATV) 300 mg, Atazanavir (ATV) 400 mg, Ritonavir (rtv) 100 mg
- Where
- 18 sites in United States, Argentina and 3 more
- Volunteers
- 50 people
- Sponsor
- Janssen R&D Ireland
HIV-1-infection
Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection
This study is designed to assess the safety and pharmacokinetic profile of 800 mg Trogarzo once every two weeks administered via "IV Push" or intramuscular injection.
- Trial name
- NCT03913195
- Testing
- ibalizumab-uiyk
- Where
- 4 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- TaiMed Biologics Inc.
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