Clinical trials: HIV
HIV
Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1
The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks.
- Trial name
- TMB-202 (NCT00784147)
- Testing
- Ibalizumab
- Where
- 30 sites in United States, Puerto Rico
- Volunteers
- 113 people
- Sponsor
- TaiMed Biologics Inc.
HIV Infections
Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents
Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class. This study evaluated the pharmacokinetics (PK), safety, tolerability of and immune response to DTG when used concurrently with optimized background therapy…
- Trial name
- NCT01302847
- Testing
- DTG film-coated tablets, DTG granules for suspension, DTG dispersible tablets
- Where
- 33 sites in United States, Botswana and 6 more
- Volunteers
- 181 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Adolescent Behavior, Hiv
Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3)
The investigators will conduct a Phase III cluster randomized controlled trial (cRCT) to evaluate the effectiveness of the implementation of a data-informed stepped care (DiSC) intervention for HIV treatment management among…
- Trial name
- NCT05007717
- Testing
- Data-informed Stepped Care (DiSC)
- Where
- 24 sites in Kenya
- Volunteers
- 1,911 people
- Sponsor
- University of Washington
HIV, Cardiovascular Diseases
Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults
People with HIV are at risk for cardiovascular disease (CVD). This study evaluated the use of pitavastatin to reduce the risk of CVD in adults with HIV on antiretroviral therapy (ART).
- Trial name
- REPRIEVE (NCT02344290)
- Testing
- Pitavastatin
- Where
- 137 sites in United States, Botswana and 11 more
- Volunteers
- 7,769 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Tambua Mapema Plus - to Discover HIV Infection Early and Prevent Onward Transmission
This study will assess the impact of an HIV-1 RNA testing intervention targeting adult patients aged 18-39 years who seek urgent care for symptoms at primary care facilities and meet specific risk criteria for acute HIV…
- Trial name
- TMP (NCT03508908)
- Testing
- HIV-1 RNA testing
- Where
- Kenya
- Volunteers
- 2,887 people
- Sponsor
- University of Oxford
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.
Acute Hepatitis C, Human Immunodeficiency Virus
Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCV
New and recently EMA/FDA approved direct acting antiviral (DAA) combination therapies cure 95% or more of the patients chronically infected with HCV genotype 1 and 4.
- Conditions
- Acute Hepatitis C, Human Immunodeficiency Virus, Hepatitis C
- Trial name
- DAHHS-2 (NCT02600325)
- Testing
- Grazoprevir/Elbasvir 100mg/50mg
- Where
- 9 sites in Belgium, Netherlands
- Volunteers
- 80 people
- Sponsor
- Erasmus Medical Center
HIV Infections
Artery Elasticity After Switch From Epzicom to Truvada
Recent research as suggested that use of the HIV medication abacavir (Ziagen, or co-formulated with lamivudine as Epzicom) may increase risk for heart disease, though findings from multiple studies have been inconsistent.
- Trial name
- NCT00998582
- Testing
- Tenofovir disoproxil
- Where
- 2 sites in United States
- Volunteers
- 27 people
- Sponsor
- Hennepin Healthcare Research Institute
HIV Infections
Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine
Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for malaria treatment and prevention, and it also has…
- Trial name
- NCT00308620
- Testing
- chloroquine phosphate
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- University of Minnesota
HIV Infection, Vaginal Atrophy
Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial
During menopause, there is a decrease in a hormone estrogen, which leads to aging of the vagina. Vaginal aging includes changes in the type and amount of healthy bacteria in the vagina, inflammation and a breakdown of natural…
- Conditions
- HIV Infection, Vaginal Atrophy, Menopause, Menopause Related Conditions
- Trial name
- NCT04079218
- Testing
- Estradiol Vaginal Insert
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Kerry Murphy
Hepatitis C Virus Infection, Response to Therapy of, Human Immunodeficiency Virus
CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS
This study is being done to compare three strategies to deliver HCV treatment with ledipasvir/sofosbuvir which is an approved therapy which is administered as one tablet by mouth daily for 12 weeks.
- Trial name
- CHAMPS (NCT02402218)
- Testing
- Usual care plus peer-mentors, Usual care plus incentives, Usual Care
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- Johns Hopkins University
HIV-1-infection, Hypertension
Assess and Adapt to the Impact of COVID-19 on CVD Self-Management and Prevention Care in Adults Living With HIV
Social distancing measures put in place to combat the COVID-19 disease pandemic may increase social isolation and impact cardiovascular disease prevention behaviors among people living with HIV (PLWH).
- Trial name
- AAIM-High (NCT04661813)
- Testing
- EXTRA-CVD Virtual Care
- Where
- 3 sites in United States
- Volunteers
- 81 people
- Sponsor
- Case Western Reserve University
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
Study to Evaluate Pharmacokinetics, Safety and Tolerability of Dolutegravir and Rilpivirine (JULUCA™) 50 Milligram (mg)/25 mg Tablets in Healthy Subjects of Japanese Descent
Dolutegravir (DTG), a human immunodeficiency virus (HIV)-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI), are each approved in the United States (US), European…
- Trial name
- NCT03984838
- Testing
- JULUCA (Dolutegravir and Rilpivirine) 50mg/25mg FDC tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV, Depression
HIV Translating Initiatives for Depression Into Effective Solutions
This study is a randomized trial designed to test and refine a collaborative care model for treating depression in VA patients with HIV.
- Trial name
- HI-TIDES (NCT00304915)
- Testing
- Collaborative Care Interventions
- Where
- 3 sites in United States
- Volunteers
- 249 people
- Sponsor
- VA Office of Research and Development
Human Immunodeficiency Virus
Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women
This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4 weeks in postmenopausal women over 12 weeks of product use.
- Trial name
- NCT02010593
- Testing
- Dapivirine Vaginal Ring
- Where
- 3 sites in United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV (Human Immunodeficiency Virus), AIDS (Acquired Immunodeficiency Syndrome)
Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms
The purpose of this study is to use technology to improve symptom status and ultimately improve patient centered outcomes in people living with HIV/AIDS (PLWHA).
- Trial name
- VIP-HANA (NCT03182738)
- Testing
- VIP app without HIV-related symptom strategies., VIP app that delivers HIV-related symptom strategies.
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Columbia University
Human Immunodeficiency Virus
Improving Prognosis in HIV Infection
The primary objective of this study is to assess the safety of probiotics in cART-treated immunologic non-responder (INR) patients with chronic HIV infection.
- Trial name
- NCT02640625
- Testing
- Probiotic compound
- Where
- Norway
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Oslo University Hospital
HIV Infection
IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women
This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not…
- Trial name
- NCT00955968
- Testing
- Highly active antiretroviral therapy (HAART)
- Where
- 50 sites in United States, Argentina and 7 more
- Volunteers
- 1,653 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
HIV/AIDS
LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care
Investigators will develop and pilot test a culturally tailored, trauma-informed smartphone app, called LinkPositively, for Black WLHA affected by interpersonal violence.
- Trial name
- NCT04199052
- Testing
- LinkPositively
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- University of California, San Diego