Clinical trials: Immunodeficiency
HIV Infections
Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants
The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is virologically suppressed on an integrase inhibitor…
- Trial name
- NCT02938520
- Testing
- Cabotegravir (CAB) tablet, Rilpivirine (RPV) tablet, Cabotegravir - Injectable Suspension (CAB LA)
- Where
- 108 sites in United States, Canada and 9 more
- Volunteers
- 631 people
- Sponsor
- ViiV Healthcare
HIV Infections
Vitamin D Supplementation in HIV Youth
The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.
- Trial name
- NCT01523496
- Testing
- Vitamin D control dose, Vitamin D supplementation-
- Where
- 2 sites in United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
HIV Infections
Dolutegravir Pediatric Liquid Formulation Study
This is an open-label, single-center, single dose, non-randomized, sequential, fixed-sequence study, which will evaluate pharmacokinetics (PK) of dolutegravir (DTG) in healthy adult subjects.
- Trial name
- NCT03921723
- Testing
- Dolutegravir dispersible tablet, Dolutegravir oral suspension, Dolutegravir oral solution
- Where
- United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV, HIV Infections
Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir…
- Trial name
- NCT01780506
- Testing
- E/C/F/TAF, E/C/F/TDF
- Where
- 117 sites in United States, Australia and 10 more
- Volunteers
- 872 people
- Sponsor
- Gilead Sciences
NAFLD, NASH - Nonalcoholic Steatohepatitis
Vitamin E for NASH Treatment in HIV Infected Individuals
The purpose of this study is to see how taking Vitamin E daily affects fatty liver in persons living with HIV. Subjects will have both HIV and a fatty liver and the purpose of the study is to learn if underlying liver condition…
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis, HIV Infections
- Trial name
- NCT03669133
- Testing
- Vitamin E
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Indiana University
HIV Infections, HIV-1
TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.
The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen…
- Conditions
- HIV Infections, HIV-1, Human Immunodeficiency Virus Type 1
- Trial name
- NCT00540449
- Testing
- TMC278, Efavirenz
- Where
- 92 sites in United States, Argentina and 18 more
- Volunteers
- 694 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infections, Fatigue
Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS
This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS.
- Trial name
- NCT00737204
- Testing
- Armodafinil
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- New York State Psychiatric Institute
HIV Coinfection
A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B
To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.
- Trial name
- NCT01327547
- Testing
- Maraviroc
- Where
- 48 sites in United States, Czechia and 7 more
- Volunteers
- 138 people
- Sponsor
- ViiV Healthcare
Immunodeficiency Virus Type 1, Human
A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects
The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC…
- Trial name
- NCT02431247
- Testing
- Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC, DRV/COBI FDC, FTC/TDF FDC
- Where
- 80 sites in United States, Belgium and 8 more
- Volunteers
- 725 people
- Sponsor
- Janssen Sciences Ireland UC
HIV-1 Infection
Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)
This study will evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of 3 doses of islatravir (MK-8591) in combination with doravirine (DOR) and lamivudine (3TC) administered to antiretroviral…
- Trial name
- NCT03272347
- Testing
- Islatravir, Doravirine, Lamivudine
- Where
- 26 sites in United States, Chile and 2 more
- Volunteers
- 123 people
- Sponsor
- Merck Sharp & Dohme LLC
Drug Use Stigma in HIV Treatment Clinics
Addressing Drug Use Stigma in Human Immunodeficiency Virus (HIV) Care and Treatment Clinics in Tanzania
The goal of this study is to adapt and pilot an effective health facility HIV stigma-reduction intervention to address drug use stigma in human immunodeficiency Virus (HIV) Care and Treatment clinics (CTCs) in Tanzania, a barrier…
- Trial name
- NCT04863898
- Testing
- Drug-use stigma reduction intervention for HIV care and treatment clinic staff
- Where
- 7 sites in Tanzania
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- RTI International
HIV Infections
Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019
Dolutegravir is a potent integrase strand transfer inhibitor. Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) is a fixed dose combination regimen containing two nucleoside reverse transcriptase inhibitors and dolutegravir.
- Trial name
- NCT03016533
- Testing
- Dolutegravir film-coated tablets, Dolutegravir film-coated dispersible tablets, ABC/DTG/3TC immediate release tablets
- Where
- 17 sites in United States, Botswana and 5 more
- Volunteers
- 100 people
- Sponsor
- ViiV Healthcare
Human Immunodeficiency Virus, Depression
Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa
The purpose of this study is to test the efficacy of Our Family Our Future, an integrated intervention for preventing HIV and depression onset among adolescents.
- Conditions
- Human Immunodeficiency Virus, Depression, Sexually Transmitted Diseases
- Trial name
- NCT03231358
- Testing
- Our Family Our Future
- Where
- South Africa
- Volunteers
- 1,758 people, healthy volunteers welcome
- Sponsor
- Brown University
HIV/AIDS
A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans
Project Rise is a randomized controlled trial (RCT) of an innovative, culturally congruent treatment education (TE) intervention for African Americans with HIV that targets cultural and social issues contributing to health…
- Trial name
- NCT03331978
- Testing
- Rise - Treatment Education
- Where
- United States
- Volunteers
- 306 people
- Sponsor
- RAND
Human Immunodeficiency Virus, Hepatitis C
Computer-based Intervention for Alcohol-using HIV/HCV+ Women
The study harnessed the multidisciplinary expertise of our research team to develop a brief, computer-based, alcohol reduction intervention tailored for HIV/HCV co-infected women and evaluate its efficacy.
- Conditions
- Human Immunodeficiency Virus, Hepatitis C, Alcohol Abuse
- Trial name
- NCT03362476
- Testing
- Computer-based alcohol reduction intervention, Brief clinician-delivered MET, Standard of care
- Where
- 2 sites in United States, Russia
- Volunteers
- 200 people
- Sponsor
- New York University
Hereditary Angioedema, Angioneurotic Edema
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening.
- Trial name
- NCT00225147
- Testing
- Recombinant Human C1 Inhibitor
- Where
- Netherlands
- Volunteers
- 77 people
- Sponsor
- Pharming Technologies B.V.
HIV/AIDS
Community Health Worker And MHealth to ImProve Viral Suppression
The overall goal of this study is to evaluate the effects of the CHAMPS intervention for people living with HIV (PLWH) in a randomized controlled trial.
- Trial name
- CHAMPS (NCT04562649)
- Testing
- Wise App with medication adherence reminders, CHW Sessions
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- Columbia University
Infection, Human Immunodeficiency Virus, HIV Infections
Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers
Cabotegravir (CAB) long-acting (LA) is a promising candidate for human immunodeficiency virus (HIV) pre exposure prophylaxis (PrEP) due to its potent antiretroviral activity and infrequent dosing requirements.
- Trial name
- NCT02478463
- Testing
- Cabotegravir tablet 30 mg once daily for 28 days., Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1.
- Where
- 2 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Human Immunodeficiency Virus-type 1 Infection
A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment
The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to standard treatment) in terms of the percentage of patients who have plasma human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid…
- Trial name
- SALIF (NCT01709084)
- Testing
- Rilpivirine, Efavirenz, Tenofovir disoproxil fumarate
- Where
- 18 sites in Cameroon, Kenya and 4 more
- Volunteers
- 426 people
- Sponsor
- Janssen-Cilag International NV
HIV Infections
Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa
This study will evaluate the preventive vaccine efficacy, safety, and tolerability of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South African adults over 24 months and potentially up to 36 months…
- Trial name
- HVTN702 (NCT02968849)
- Testing
- ALVAC-HIV (vCP2438), Bivalent Subtype C gp120/MF59
- Where
- 14 sites in South Africa
- Volunteers
- 5,404 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)