Clinical trials: AIDS and Infections
mHealth, PMTCT
Mobile Strategies for Women's and Children's Health: Optimizing Adherence and Efficacy of PMTCT/ART
The investigators are conducting a 3-arm randomized trial comparing the effects of unidirectional SMS (ie: "push" messaging to participant) vs. bidirectional SMS dialogue between participant and provider vs.
- Conditions
- mHealth, PMTCT, Adherence, Medication, SMS
- Trial name
- Mobile WAChx (NCT02400671)
- Testing
- SMS messaging
- Where
- 6 sites in Kenya
- Volunteers
- 825 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV 1 Infection, HIV 2 Infection
A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
The objectives of this study are as follows: To evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care…
- Conditions
- HIV 1 Infection, HIV 2 Infection, Syphilis Infection, Hepatitis B Infection
- Trial name
- NCT07563309
- Testing
- TruPlex HIV/HepB/Syphilis Rapid Test
- Where
- 3 sites in South Africa
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
HIV Infections
Safety and Immune Response Study of the Vaccine ALVAC vCP1452 Alone or in Combination With AIDSVAX B/B
The purpose of this study is to see if the vaccines tested are safe when given alone and when given together, and how the immune system responds to the vaccines.
- Trial name
- NCT00007332
- Testing
- ALVAC(2)120(B,MN)GNP (vCP1452), MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
- Where
- 17 sites in United States
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Human Immunodeficiency Virus
Problems With Immune Recovery in the Gut Tissue
The aim of this study is to find out if the process of HIV replication in the lymph tissue and gut tissue of people taking HIV drugs causes long-term damage to the ability of the gut to protect you from other infections and…
- Trial name
- NCT01460433
- Testing
- Genital and rectal swabbing
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Gonorrhea Female, Chlamydia Females
The Integrated Female Sexually Transmitted Infection Testing for HIV Epidemic Control Through PrEP (IN-STEP) Study
Globally, new HIV infections are concentrated in eastern and southern Africa where the infections are largely acquired by women outside of known key populations.
- Conditions
- Gonorrhea Female, Chlamydia Females, Syphilis Female, Trichomonas Vaginalis
- Trial name
- IN-STEP (NCT06743204)
- Testing
- Self-Reported Risk Screening for PrEP and Diagnostic STI testing, Self-reported risk screening for PrEP and syndromic management for STIs
- Where
- Uganda
- Volunteers
- 5,560 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Human Immunodeficiency Virus, HIV
Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of an islatravir (ISL)-eluting implant.
- Trial name
- NCT05115838
- Testing
- Islatravir
- Volunteers
- healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Quantitative and Qualitative Research for "mHealth Program to Support People Living With HIV Across the HIV Care Continuum"
The goal of this randomized control trial (RCT) is to assess the effectiveness of Amp, a mobile health (mHealth) app designed to improve outcomes along the HIV care continuum for young Black men who have sex with men (YBMSM)…
- Trial name
- VSS (NCT06181916)
- Testing
- Amp
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sentient Research
Anal Dysplasia, Human Papillomavirus
The HPV-SAVE Study Team: HPV Screening and Vaccine Evaluation in Men Who Have Sex With Men
Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide. Infection by certain high-risk oncogenic types of HPV (HR-HPV) is the major cause of several cancers in men, notably squamous cell carcinoma…
- Conditions
- Anal Dysplasia, Human Papillomavirus, Anal Cancer
- Trial name
- HPV-SAVE (NCT02503111)
- Testing
- The Hyfrecator ® 2000 Electrosurgical System, Observation Alone
- Where
- 4 sites in Canada
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Combined Point of Care Diagnostic of HIV, HBV and HCV
Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV…
- Trial name
- MAGICIEN (NCT06082336)
- Testing
- MagIA IBC test in capillary blood, MagIA IBC test in other blood matrices
- Where
- 2 sites in France
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- MagIA Diagnostics
Children With Confirmed HIV Infection, Receiving ART Regimen Containing 2 NRTIs + LPV/RTV at Standard Dose
Dosing, Safety and Pharmacokinetic Profile of Rifabutin in Children Receiving Concomitant Treatment With Kaletra
Open label pharmacokinetic RBT dose-finding study in young (≤ 5 year old) HIV-infected children receiving a LPV/RTV-based ART regimen and who have a recent history of completing TB treatment.
- Conditions
- Children With Confirmed HIV Infection, Receiving ART Regimen Containing 2 NRTIs + LPV/RTV at Standard Dose, Successfully Completed TB Treatment in the Past 2 to 6 Weeks of Enrollment
- Trial name
- RBT (NCT01259219)
- Testing
- Mycobutin
- Where
- 3 sites in South Africa
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Harriet Shezi Children's Clinic
Infection, Human Immunodeficiency Virus
Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Rilpivirine in Healthy Subjects
Treatment of human immunodeficiency virus (HIV) infection requires daily oral administration of a combination of antiretroviral drugs to reduce the patient's HIV levels.
- Trial name
- NCT02373930
- Testing
- DTG 50 mg, RPV 25 mg, DTG/RPV 50 mg/25 mg: Product Code AS
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Microbial Colonization
Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women
The investigators are doing a study on the bacteria that normally live in the vagina and what effect, if any, Depo-Provera has on the bacteria.
- Trial name
- AIMS (NCT03196492)
- Testing
- No intervention
- Where
- United States
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
HIV Infections
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants
The primary purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (PK) profiles of two different cabotegravir formulations in healthy adult participants.
- Trial name
- NCT06033547
- Testing
- Cabotegravir Formulation F, Cabotegravir Formulation G
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Hepatitis C, HIV
Potential for Drug-drug Interactions Between Boceprevir and Etravirine in HIV/Hepatitis C Virus Negative Volunteers
The investigators believe that boceprevir's drug concentrations will be reduced when administered in combination with etravirine.
- Trial name
- NCT01427504
- Testing
- boceprevir; etravirine
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
HIV Infections
A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants
This study evaluates the PK, safety, and tolerability of a single increasing dose of VH4367310, a cabotegravir (CAB) prodrug, when administered intramuscularly in healthy adult participants 18 to 55 years of age.
- Trial name
- NCT07818915
- Testing
- VH4367310
- Where
- 2 sites in United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV-1
PEPI-TiDP23-C103: First-in-Human Study to Examine the Safety, Tolerability, and Plasma Pharmacokinetics of Increasing Single and Repeated Oral Doses of TMC558445 and of a Combined Single Day Dosing of Oral TMC558445 and Oral TMC310911 and Also Oral Darunavir
The purpose of the study is to determine the safety, tolerability and plasma pharmacokinetics (pk) (i.e., the levels of TMC558445 circulating in your blood over time) of increasing single oral doses of TMC558445 and of multiple…
- Trial name
- NCT00838760
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Herpes Zoster
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Background: Shingles is a painful, blistering rash caused by the same virus that causes chickenpox. Shingrix is a vaccine approved to prevent shingles in healthy adults over age 50 and in immunocompromised adults over age 18.
- Trial name
- NCT05580458
- Testing
- Shingrix
- Where
- United States
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Bacterial Vaginosis, HIV
Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity
The investigators propose to explore the hypothesis-supported by limited data-that a contraceptive vaginal ring (CVR) that is commonly used in the United States, the NuvaRing, will enhance women's genital and reproductive health.
- Trial name
- NCT02445989
- Testing
- NuvaRing
- Where
- Kenya
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
Computerized Counseling to Promote Positive Prevention and HIV Health in Kenya
The purpose of this study is to see if a computerized counseling tool helps patients reduce their sexual transmission risk and improve their antiretroviral adherence.
- Trial name
- CARE+ Kenya (NCT01015989)
- Testing
- CARE+ Kenya brief computer risk assessment session, CARE+ Kenya computer counseling session
- Where
- 2 sites in Kenya
- Volunteers
- 236 people, healthy volunteers welcome
- Sponsor
- New York University
HIV Infections
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women
This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected women.
- Trial name
- NCT02568215
- Testing
- VRC01
- Where
- 21 sites in Botswana, Kenya and 5 more
- Volunteers
- 1,924 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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