Clinical trials: HIV 1 Infection, active
HIV I Infection, Tuberculosis
Evaluating the Safety and Immunogenicity of MTBVAC
The purpose of this study is to evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa
- Trial name
- HVTN605A5421 (NCT05947890)
- Testing
- MTBVAC, BCG
- Where
- 16 sites in South Africa
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network
HIV -1 Infection
Safety Study of MucoCept-CVN
MucoCept-CVN uses a Lactobacillus strain native to the human vagina that is modified into a live biotherapeutic product (LBP) that continuously expresses a potent anti-HIV drug.
- Trial name
- NCT07181486
- Testing
- Live Biotherapeutic Product L. jensenii 1153-1666
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Craig Cohen, MD, MPH
HIV-1-infection
IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study
Purpose: To assess the safety and tolerability of a single dose of IAP086 in persons with HIV suppressed on stable ART Participants: 30 people from UNC within 18 to 70years of age.
- Trial name
- NCT07596888
- Testing
- IAP086 0.3 mcg/kg, IAP086 1 mcg/kg, IAP086 3 mcg/kg
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Uterine Cervical Neoplasms, HIV I Infection
Cervical Pre-cancer Treatment Failure Among Women Living With HIV in Zimbabwe
The goal of this observational study is to improve cervical pre-cancer treatment outcomes among women living with HIV (WLWH), particularly in low and middle income countries (LMICs), by generating the evidence needed for…
- Conditions
- Uterine Cervical Neoplasms, HIV I Infection, HPV Infection
- Trial name
- NCT07202936
- Where
- Zimbabwe
- Volunteers
- 168 people
- Sponsor
- University of Bern
HIV Infections
A Clinical Trial to Evaluate the Safety and Immunogenicity of CH505M5 N197D mRNA-gp160 Followed by CH505 TF mRNA-gp160 in Adults in Overall Good Health Without HIV
This is a multicenter, open-label, non-randomized, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160.
- Trial name
- NCT06557785
- Testing
- CH505M5 N197D mRNA-gp160, CH505 TF mRNA-gp160
- Where
- 7 sites in United States, Thailand
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption
The purpose of this study is to evaluate the safety, tolerability, and efficacy of N-803, an IL-15 superagonist, with or without combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic…
- Trial name
- NCT04340596
- Testing
- N-803 (IL-15 Superagonist), VRC07-523LS, 10-1074
- Where
- 14 sites in United States
- Volunteers
- 118 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV -1 Infection, Mental Health Issue
Integrating iSYV Within HIV Clinical Care for Youth Living With HIV in Tanzania
Youth living with HIV (YLWH) experience mental health (MH) challenges that compromise their HIV care. Though the MH gap is well described, MH service delivery to YLWH is rare, especially in low resource settings.
- Trial name
- NCT07621510
- Testing
- iSYV (integrated Sauti ya Vijana; The Voice of Youth), mHealth, eSOC
- Where
- Tanzania
- Volunteers
- 5,000 people
- Sponsor
- Duke University
HIV-1-infection, Anxiety Depression
Research on the Psychological Status of Patients With HIV-1 Infection
The goal of this observational study is to investigate the neuropsychological states of People Living With HIV(PLWH), the prevalence of social and psychological stress adaptation overload and poor episodic memory in PLWH.
- Trial name
- NCT07080138
- Testing
- All kinds of INSTI medications, All kinds of conventional medications
- Volunteers
- 500 people
- Sponsor
- Shanxi Bethune Hospital
Cryptococcal Antigenemia, HIV-1-infection
Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers
This randomized clinical trial will evaluate the optimal duration of fluconazole therapy and timing of antiretroviral therapy initiation among HIV-infected persons with asymptomatic cryptococcal antigenemia and low cryptococcal…
- Conditions
- Cryptococcal Antigenemia, HIV-1-infection, Cryptococcal Infection, Cryptococcal Meningitis
- Trial name
- NCT07743593
- Testing
- Immediate ART Initiation, Delayed ART Initiation, 10-Week Fluconazole
- Where
- Uganda
- Volunteers
- 505 people
- Sponsor
- University of Minnesota
HIV 1 Infection
Study on Retention in Care and on Clinical Chracteristics of HIV-infected Women Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIKWO).
Women are an underrepresented population in clinical studies on HIV and antiretroviral therapy. This study aims to help bridge this gap by providing real-world data on therapeutic management with B/F/TAF (Biktarvy) in an…
- Trial name
- BIKWO (NCT07859904)
- Testing
- Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Ente Ospedaliero Ospedali Galliera
HIV/AIDS, HIV-1-infection
Simplifying Treatment and Monitoring for HIV (STREAM HIV)
This study seeks to determine the clinical efficacy and cost effectiveness of implementing an integrated model for HIV monitoring using point of care (POC) tenofovir (TFV) adherence testing and POC viral load (VL) monitoring in…
- Trial name
- NCT04341779
- Testing
- Point-of-care viral load testing and tenofovir adherence testing
- Where
- South Africa
- Volunteers
- 539 people
- Sponsor
- University of Washington
HIV Infections
Development of a New Family of HIV Latency Regulators (LRAs) Targeting the Tat Viral Protein
Antiretroviral therapy (ART) prevents HIV from multiplying. However, if people living with HIV stop taking ART, the virus quickly reappears in their blood due to the random activation of hidden infected cells.
- Trial name
- TatLat (NCT06441123)
- Testing
- Blood Sampling
- Where
- France
- Volunteers
- 24 people
- Sponsor
- University Hospital, Montpellier
HIV Infections With Multi Drug Resistant Virus
Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance
In the SHIELD study, the study sponsor seeks to assess safety, PK and antiviral activity for children and adolescents with dual or triple class resistance.
- Trial name
- NCT04648280
- Testing
- Fostemsavir
- Where
- 8 sites in United States, Brazil and 1 more
- Volunteers
- 60 people
- Sponsor
- PENTA Foundation
HIV-1-infection
Observational PIC Destination Cohort
This study is being done to see if people who control HIV without antiretroviral therapy (ART) after receiving an intervention can remain off ART safely.
- Trial name
- NCT05985642
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV-1-infection
Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch
Combination antiretroviral therapy (cART) HIV treatments are associated with increased quality of life, and a normalisation of life expectancy in people living with HIV.
- Trial name
- DORDOL (NCT04892654)
- Testing
- Doravirine, Dolutegravir, Triple cART regimen
- Where
- 3 sites in United Kingdom
- Volunteers
- 150 people
- Sponsor
- Chelsea and Westminster NHS Foundation Trust
HIV-1-infection, Opioid Use Disorder
Evaluation of Switch to Dolutegravir/Lamivudine (DTG/3TC) From Current Suppressive Antiretroviral Therapy in People Living With HIV (PLWH) Receiving Opioid Agonist Therapy (OAT)
The goal of this clinical trial is to determine the efficacy of Dolutegravir/Lamivudine (DTG/3TC), or "Dovato", in virally-suppressed (HIV-1 RNA < 200 copies/mL) individuals receiving opioid agonist therapy such as methadone…
- Trial name
- NCT06580873
- Testing
- DOVATO
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Saskatchewan Health Authority - Regina Area
HIV-1-infection
Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully
The main objective of the MODULO trial is to compare (non-inferiority) the capacity of DOR/3TC and DTG/3TC two-drug regimens of maintain virological success at W48 in people living with HIV virus ( PLWH) with suppressed HIV…
- Trial name
- MODULO (NCT06774872)
- Testing
- Doravirine 100Mg Tab and Lamivudine 300 Mg Tab, Dolutegravir 50mg Tab and Lamivudine 300 Mg Tab
- Where
- France
- Volunteers
- 408 people
- Sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
HIV -1 Infection, HIV (Human Immunodeficiency Virus)
REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE
Managing HIV well requires taking antiretroviral therapy (ART) every day, but many people living with HIV experience interruptions in their treatment.
- Conditions
- HIV -1 Infection, HIV (Human Immunodeficiency Virus), HIV, HIV 1 Infection
- Trial name
- REINITIATE (NCT07476339)
- Testing
- Bictegravir, emtricitabine, and tenofovir alafenamide
- Where
- 10 sites in United States
- Volunteers
- 200 people
- Sponsor
- CAN Community Health
HIV Infections
Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184
The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.
- Trial name
- NCT07636928
- Testing
- VH4524184, [14C]VH4524184 microdose, [14C]VH4524184
- Where
- Netherlands
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Hypertension, Dyslipidemias
Addressing Barriers to Achieving Cardiometabolic Disorders Prevention and Treatment Goals for PLWH in the SE US
This study has 3 aims. Aim 1: Identify social determinants of cardiometabolic health and determine facilitators and modifiable barriers in achieving treatment goals.
- Conditions
- Hypertension, Dyslipidemias, Type 2 Diabetes, HIV-1-infection
- Trial name
- NCT05129345
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Duke University