HIV/AIDS Clinical Trial
Official title:
A Phase 2b Study to Evaluate the Efficacy, Safety and PK of a Combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide Fumarate for Treatment of HIV-1 Infection in Patients With DS-TB on a Rifampicin-based Regimen
This study is being conducted to assess the antiretroviral activity of a fixed-drug, single tablet, combination of Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir alafenamide 25mg (Biktarvy®) dosed twice daily in HIV-1 infected, ART-naïve patients with TB co-infection receiving a rifampicin-based tuberculosis (TB) treatment regimen. This study will assess the activity of Bictegravir and dolutegravir-containing ART regimens in patients with drug-susceptible TB through 48 weeks
Primary objective: To characterize viral suppression rates (proportion of patients with suppressed viral load) at week 24 in the BIC arm Secondary objectives: To characterize viral suppression rates at weeks 12, 24 and 48 in the standard of care treatment (SOC) arm (currently, TDF 300mg/3TC 300mg/DTG 50mg) and at weeks 12 and 48 in the BIC/FTC/TAF arm. To compare the pharmacokinetics (PK) of BIC when given twice daily and co-administered with Rifampicin during tuberculosis treatment vs when given alone after discontinuation of Rifampicin To assess the incidence of TB associated IRIS in each arm, through week 24. To characterize the tolerability of treatment in each arm by assessing frequency of clinician-initiated treatment interruptions or switches through week 48. To assess frequency of ART drug resistance mutations in participants with detectable viral load at study visit weeks 24 and 48. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
| Completed |
NCT03289676 -
Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV
|
Phase 1 | |
| Completed |
NCT03215901 -
Life Plans Intervention Study
|
N/A | |
| Completed |
NCT03268551 -
MEMO-Medical Marijuana and Opioids Study
|
||
| Active, not recruiting |
NCT04064567 -
Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK
|
N/A | |
| Completed |
NCT04013295 -
Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya
|
N/A | |
| Recruiting |
NCT04405700 -
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
|
||
| Recruiting |
NCT03984136 -
HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM
|
N/A | |
| Completed |
NCT02928900 -
Patient Actor Training to Improve HIV Services for Adolescents in Kenya
|
N/A | |
| Recruiting |
NCT03268109 -
COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
|
||
| Completed |
NCT02797262 -
Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System
|
N/A | |
| Completed |
NCT02376582 -
Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS
|
Phase 1 | |
| Completed |
NCT01957865 -
Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
|
N/A | |
| Completed |
NCT01616940 -
Minority AIDS Initiative Retention and Re-Engagement Project
|
N/A | |
| Terminated |
NCT01443923 -
Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV
|
Phase 4 | |
| Completed |
NCT01910714 -
Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth
|
N/A | |
| Completed |
NCT01084421 -
A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos
|
N/A | |
| Completed |
NCT01596322 -
International HIV Antiretroviral Adherence, Resistance and Survival
|
N/A | |
| Completed |
NCT03643705 -
A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention
|
N/A | |
| Completed |
NCT03923231 -
Pharmacokinetics of Atazanavir in Special Populations
|