HIV/AIDS Clinical Trial
Official title:
Darunavir/Cobicistat and Dolutegravir to Maintain Virologic Suppression and Reduce NRTI-associated Toxicity (The 'deNUC' Study; TMC114HIV2030)
This is a clinical research study to see if switching to Darunavir/Cobicistat ((PREZCOBIX™, DRV/COBI ) and Dolutegrivir (Tivicay®, DTG) in HIV-infected individuals with undetectable HIV viral load on nucleos(t)ide reverse transcriptase inhibitor (NRTI)-containing therapy will be effective in maintaining virologic suppression at 48 weeks of treatment.
NRTIs have been a stalwart for treatment in both the pre- and post-ART eras. However, NRTIs have numerous toxicities partly due to the fact that they are analogs of naturally occurring nucleotides and interfere with the activity of numerous cellular functions. In highly treatment-experienced individuals with more than two active drugs in their salvage regimens, an NRTI-sparing regimen has been shown to be non-inferior to an NRTI-containing regimen [33]. However, studies with NRTI-sparing regimens not consisting of more than two active medications have generally been disappointing. One limitation of earlier NRTI-sparing regimens has been a higher pill burden than more standard regimens. However, the approvals of DTG and the co-formulated DRV/COBI, both with well-established antiviral activities, may allow for a compact, effective, NRTI-sparing regimen. A switch to DTG/DRV/COBI in virologically suppressed HIV-infected individuals has the potential to avoid NRTI-associated toxicity while maintaining virologic suppression. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
| Completed |
NCT03215901 -
Life Plans Intervention Study
|
N/A | |
| Completed |
NCT03289676 -
Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV
|
Phase 1 | |
| 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 | |
| Terminated |
NCT01443923 -
Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV
|
Phase 4 | |
| Completed |
NCT01616940 -
Minority AIDS Initiative Retention and Re-Engagement Project
|
N/A | |
| 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
|