Clinical trials: Anti-Retroviral Agents
HIV, Antiretroviral Therapy
Survey of Procedures and Resources for Initiating Treatment of HIV in Africa-Malawi
In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization (WHO) called for rapid or same-day initiation of antiretroviral treatment (ART) for eligible patients testing positive for…
- Trial name
- SPRINT-Malawi (NCT04468399)
- Testing
- Routine medical record data collection, Interviews with service providers
- Where
- 2 sites in Malawi, South Africa
- Volunteers
- 1,781 people
- Sponsor
- Boston University
HIV Infections
A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.
To compare the safety, tolerance, early antiviral activity, and durability of antiviral response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir (IDV) arm.
- Trial name
- NCT00002199
- Testing
- Indinavir sulfate, Lamivudine/Zidovudine, Abacavir sulfate
- Where
- United States
- Volunteers
- 550 people
- Sponsor
- Glaxo Wellcome
HIV - Human Immunodeficiency Virus, HIV Antiretroviral Therapy (ART) Adherence
Improving the HIV Care Continuum With mHealth Technology
Youth living with HIV (YLHIV) face barriers to engagement and retention in HIV care, show poor medication adherence, and often fail to achieve and maintain viral suppression.
- Conditions
- HIV - Human Immunodeficiency Virus, HIV Antiretroviral Therapy (ART) Adherence, mHealth Application, mHealth Intervention
- Trial name
- NCT07631104
- Testing
- MindBodyU Intervention
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of South Carolina
HIV Infections
Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
This study will compare an anti-HIV drug combination of protease inhibitor plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) to one that includes three nucleoside reverse transcriptase inhibitors (NRTIs) plus an NNRTI.
- Trial name
- NCT00004855
- Testing
- Lopinavir/Ritonavir, Abacavir sulfate, Nevirapine
- Where
- 23 sites in United States
- Volunteers
- 55 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
HIV Infections
Evaluation of Specific Infection-Fighting Cells For Prediction of Immune Response to Anti-HIV and Immune-Boosting Medication
The purpose of this study is to see if the amount of stem cells (cells that can develop into many kinds of cells) in the blood before anti-HIV drugs are taken can predict if the immune system will become stronger after anti-HIV…
- Trial name
- NCT00006578
- Testing
- Ritonavir, Abacavir sulfate, Amprenavir
- Where
- 5 sites in United States
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Study to See If Taking One or Two Extra Drugs Can Lower HIV Levels in Patients Who Have Failed Their Anti-HIV Drug Treatment
The purpose of this study is to see if adding 1 or 2 drugs to the anti-HIV therapy of patients whose HIV levels increased while taking their anti-HIV drugs can lower viral load (amount of HIV in the blood) and keep it low up to…
- Trial name
- NCT00006152
- Testing
- Ritonavir, Abacavir sulfate, Amprenavir
- Where
- 13 sites in United States
- Volunteers
- 42 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy, HIV Infections
Influence of the MDR1 Genotype on Blood Levels of Indinavir and Saquinavir in Healthy Volunteers
This study will examine whether a particular type of gene (MDR1) in the body can affect blood levels of two protease inhibitors, indinavir and saquinavir, which are used to treat people with HIV.
- Trial name
- NCT00050180
- Testing
- Midazolam, Indinavir, Saquinavir
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
Contraception
Acceptability of Depo-subQ in Uniject
This is an observational study to assess the experience of current depot medroxyprogesterone acetate (DMPA) intramuscular (IM) clients and providers when they try Depo-subQ in Uniject and offer recommendations for the…
- Trial name
- NCT01667276
- Where
- 2 sites in Senegal, Uganda
- Volunteers
- 476 people, healthy volunteers welcome
- Sponsor
- FHI 360
HIV, Opioid Dependence
Study of Integrating Antiretroviral Therapy With Methadone Treatment for People Who Inject Drugs
To improve ART initiation among people who inject drugs, the investigators propose to develop and pilot a multi-component Integrated Methadone and Antiretroviral Therapy strategy (IMAT) in Dar es Salaam, Tanzania.
- Trial name
- IMAT (NCT02167425)
- Testing
- IMAT
- Volunteers
- 800 people
- Sponsor
- Pangaea Global AIDS Foundation
HIV Infections
FREE Study: Efficacy and Toxicity of Trizivir
Antiretroviral naïve patients with <350 xE6/l CD4 cells and a HIV-viral load of > 30.000 cop/ml are started on combivir ® and Kaletra ®.
- Trial name
- NCT00405925
- Testing
- Trizivir, zidovudine,lamivudine,abacavir
- Where
- Netherlands
- Volunteers
- 207 people
- Sponsor
- Rijnstate Hospital
HIV/AIDS
Universal Coverage of Antiretroviral Treatment in Senegal
Senegal plans a rapid scale up of HIV treatment for all people living with HIV, regardless of cluster of differentiation 4 (CD4) count or viral suppression.
- Trial name
- NCT03880006
- Testing
- Case management
- Where
- 4 sites in Senegal
- Volunteers
- 596 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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-1 Infection
Study to Evaluate Effects of Vorinostat and HXTC on Persistent HIV-1 Infection in HIV-Infected Subjects Started on Antiretroviral Therapy (ART)
This is a phase I, single-site, study to evaluate the effects of VOR and HIV-1 Antigen Expanded Specific T Cell Therapy (HXTC) on persistent HIV-1 Infection in HIV-infected individuals suppressed on ART.
- Trial name
- XTRA (NCT03212989)
- Testing
- Vorinostat, HXTC
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV
The Coach Mpilo Study: Evaluation of a Peer-led Intervention to Promote Engagement in HIV Care for Men Living With HIV
Developed in South Africa using extensive input from community members and healthcare professionals, Coach Mpilo is a peer support intervention that was designed to improve health outcomes for men living with HIV.
- Trial name
- NCT07564193
- Testing
- Coach Mpilo
- Where
- South Africa
- Volunteers
- 800 people
- Sponsor
- University of Cape Town
HIV Infection, HAART-treated
Dolutegravir + Rilpivirine Switch Study (DORISS)
The primary objective of the study is to evaluate the capacity of Dolutegravir + Rilpivirine vs. continued triple combination HAART to maintain plasma HIV RNA ≤ 50 copies/ml throughout 24 weeks in patients with plasma HIV RNA ≤…
- Conditions
- HIV Infection, HAART-treated, Virologically Controlled
- Trial name
- DORISS (NCT02069834)
- Testing
- Arm 1 (intervention), Arm 2 (control)
- Where
- 25 sites in France
- Sponsor
- Nantes University Hospital
HIV, HIV Infections
Extending HIV Care Beyond the Rural Health Center
The objective of this application is to develop and assess a system which uses non-clinician extenders to provide selected aspects of HIV care in rural western Kenya.
- Trial name
- NCT00371540
- Testing
- Home visit by community care coordinators
- Where
- Kenya
- Volunteers
- 208 people
- Sponsor
- Indiana University
HIV Infection, Metabolic Syndrome
Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience
Background: The primary goal of antiretroviral therapy is to prevent HIV-associated morbidity and mortality. The effectiveness of first-line regimens is supported by a large number of clinical trials; current concerns focus on…
- Conditions
- HIV Infection, Metabolic Syndrome, Antiretroviral Treatment
- Trial name
- TEOTL (NCT07031063)
- Testing
- DTG/3TC, Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)
- Where
- Mexico
- Volunteers
- 124 people
- Sponsor
- Instituto Mexicano del Seguro Social
HIV-positive Individuals
MyTPill: A Novel Strategy to Monitor Antiretroviral Adherence Among HIV+ Prescription Opioid Users
This study compares several different antiretroviral adherence measures, including digital pills, in HIV+ individuals who are maintained on opioid analgesics.
- Trial name
- MyTPill (NCT03978793)
- Testing
- MyTPill, a digital pill
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Ohio State University
HIV - Human Immunodeficiency Virus
CD4 Cell Count at Antiretroviral Therapy Initiation or Re- Initiation
The primary purpose of this study is to assess the burden of advanced HIV disease (CD4 cell count <200 or <350 cells/μL) among new patients and those returning to care after a gap in treatment, and the extent to which low…
- Trial name
- CAIR (NCT07760324)
- Where
- Zambia
- Volunteers
- 151 people
- Sponsor
- Centre for Infectious Disease Research in Zambia
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