Clinical trials: Immunologic Deficiency Syndrome
Healthy Volunteers
Impact of Steady State Cobicistat and Darunavir/Cobicistat on the Pharmacokinetics and Pharmacodynamics of Oral Anticoagulants (Rivaroxaban, Apixaban) in Health Volunteers
Background: Rivaroxaban and apixaban are blood thinners. People with HIV may need to take them to treat or prevent blood clots. The anti-HIV drug darunavir (DRV) can increase the amount of these blood thinners in the body.
- Trial name
- NCT03864406
- Testing
- Cobicistat, Darunavir/Cobicistat, Rivaroxaban
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
Human Immunodeficiency Virus, Perinatal Depression
Adaptation of the Friendship Bench Intervention for HIV-infected Perinatal Women in Lilongwe
In many sub-Saharan African countries, the scale-up of lifelong antiretroviral treatment (ART) to all pregnant and breastfeeding women under Option B+ has the potential to radically improve maternal health and reduce…
- Trial name
- Periscope (NCT04143009)
- Testing
- Enhanced Friendship Bench, Enhanced Standard Care (Control), Adapted Friendship Bench
- Where
- 3 sites in Malawi
- Volunteers
- 92 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV
Pre-Exposure Prophylaxis (PrEP) Provision for Ugandan Fisherfolk
This study is a pilot test of enhancements to the standard of care for providing PrEP in Ugandan fishing communities. The specific aims are to conduct a mixed-methods study assessing enhancements to the standard of care for…
- Trial name
- NCT05084716
- Testing
- Enhanced PrEP provision
- Where
- 2 sites in Uganda
- Volunteers
- 885 people, healthy volunteers welcome
- Sponsor
- RAND
HIV Infections
Kaletra and Viread in Antiretroviral Naïve Patients
Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r, 800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to <50 copies/ml in antiretroviral naïve patients…
- Trial name
- NCT00679926
- Testing
- Once daily
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Oklahoma State University Center for Health Sciences
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
HIV-1, HIV Infections
A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)
The goal of this study is to understand the safety, tolerability and immunogenicity of the Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef Vaccine (MRKAd 5 HIV-1 gag/pol/nef) vaccine in healthy human volunteers compared…
- Trial name
- NCT00849680
- Testing
- Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose), Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose), Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose)
- Volunteers
- 317 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV/AIDS, HIV Prevention
Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM)
ATN DREAM is an early phase-1, open label study to examine the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of a one-dose tenofovir (TFV) medicated douche.
- Trial name
- NCT04686279
- Testing
- Tenofovir Douche
- Where
- 3 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
HIV Infections, Pregnancy Related
Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women
The purpose of this research study is to evaluate the effect of body changes in pregnancy on doravirine concentrations, to determine what dose of doravirine should be used.
- Trial name
- NCT04900974
- Testing
- Doravirine
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections, Sexually Transmitted Diseases
Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students
This study will develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students.
- Conditions
- HIV Infections, Sexually Transmitted Diseases, Pregnancy
- Trial name
- NCT00161382
- Testing
- HIV, STD, and pregnancy prevention curriculum, Standard sexual education curriculum
- Where
- United States
- Volunteers
- 3,007 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
HIV Infections
A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247)
This study will evaluate: (1) the effect of co-administration of single doses of calcium carbonate antacid and magnesium/aluminum hydroxide antacid on the steady-state plasma pharmacokinetic profile of raltegravir in human…
- Trial name
- NCT01622673
- Testing
- Raltegravir, TUMS® Ultra Strength, MINTOX® Maximum Strength
- Volunteers
- 27 people
- Sponsor
- Merck Sharp & Dohme LLC
Infections, Papillomavirus, Papillomavirus Vaccines
Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety and immunogenicity of Cervarix in HIV infected…
- Trial name
- NCT01031069
- Testing
- GSK Biologicals' HPV vaccine 580299, Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)
- Where
- 15 sites in Brazil, Estonia and 2 more
- Volunteers
- 873 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections
Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of a 90-day intravaginal ring (IVR) containing tenofovir (TFV).
- Trial name
- NCT03670355
- Testing
- Tenofovir (TFV) IVR
- Where
- 3 sites in United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hiv
Autologous CD4 T-Cells in HIV (C34-CXCR4)
A single cohort, open-label pilot study of the safety and tolerability of a single infusion of autologous CD4+ T-cells genetically modified with an HR2, C34-peptide conjugated to the CXCR4 N-terminus using a lentiviral vector in…
- Trial name
- NCT03020524
- Testing
- Autologous CD4 T-Cells
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Pennsylvania
HIV Infections
Switching Nevirapine Immediate Release( IR) Based Regimen to Nevirapine Extended Release (XR) Based Regimen in Human Immunodeficiency Virus One (HIV-1) Infected Patients
The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at…
- Trial name
- NCT00819052
- Testing
- Nevirapine XR, Nevirapine IR
- Where
- 39 sites in United States, France and 2 more
- Volunteers
- 445 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
The Maraviroc Central Nervous System (CNS) Study
The purpose of this study is to describe the Central Nervous System exposure of maraviroc in HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at steady state.
- Trial name
- NCT00982878
- Testing
- Maraviroc
- Where
- United Kingdom
- Volunteers
- 13 people
- Sponsor
- Imperial College London
Sexually Transmitted Infections, Human Immunodeficiency Virus
Economic and Social Empowerment To Increase Upwards Mobility Among Women
The proposed research aims to pilot a multi-strategy structural intervention combining community mobilization to promote gender equity alongside an economic intervention (microfinance and business training) in order to reduce…
- Trial name
- ESTIMA (NCT02266108)
- Testing
- ESTIMA Intervention
- Where
- Mexico
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Human Immunodeficiency Virus, Mental Health
Digital Star: HIV Prevention for Youth in Mental Health Treatment
Teenagers in mental health treatment are at greater risk for HIV and other sexually transmitted infections. This greater risk comes from many factors, some of which are related to poor emotion regulation and low self-confidence.
- Trial name
- DSTAR (NCT02921841)
- Testing
- D*STAR, D*HEALTH
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Rhode Island Hospital
HIV Infections
Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Administered Rectally
The purpose of this study is to evaluate the safety and pharmacokinetics of rectal administration of a tenofovir alafenamide (TAF)/elvitegravir (EVG) insert at two dose levels in HIV-uninfected individuals.
- Trial name
- NCT04047420
- Testing
- TAF/EVG Insert
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Seropositivity, Bisexuality
Telehealth Delivery (Tele-B6)
The research team has developed an interventional group program for young men living with HIV and will be adapting it for telehealth delivery.
- Trial name
- NCT05829759
- Testing
- Tele-B6, Delayed intervention (waitlist control)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Emory University
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)
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