Health Condition 1: null- HIV 1 infection
Conditions
Interventions
Intervention1: Drug: Darunavir
Drug: Ritonavir
Drug: Etravirine
Drug: Emtricitabine/tenofovir disoproxil fumarate
Drug: Raltegravir
All are oral tablets.
Drug: Second line ART regimens are usually bas
therefore, it is distinct from Cohorts B, C, and D.
Other: SOC adherence versus SOC+CPI adherence
not participating in the adherence randomization
OR
randomized to SOC adherence
OR
randomized to SOC+CPI adherence.
Control Intervention1: Active Comparator: Cohort D: NRTI and/or DRV/RTV resistance or prior RAL exposure: Study provided drugs according to patient resistance profi
Sponsors
NIH DAIDS
Eligibility
Inclusion criteria
Inclusion criteria: HIV-1 infection Any previous combination of ARV treatment at any time with at least one regimen that contained one NNRTI and two NRTIs which was replaced with a PI-based regimen because of virologic, immunologic, or clinical treatment failure, or because of toxicity
Exclusion criteria
Exclusion criteria: Pregnancy or breast-feeding. Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry. Concurrent illness or condition that would compromise the ability to take study medication, follow the protocol, or that would make participation not in the best interest of the participant, per the site investigator. Requirement for taking any of the prohibited medications with the selected ARV study regimen, or within 14 days prior to study entry. Active tuberculosis (TB) or rifampin exposure less than 2 weeks prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Suppression rate of plasma HIV-1 RNA to â?¤200 copies/mL at 48 weeksTimepoint: Suppression rate of plasma HIV-1 RNA to â?¤200 copies/mL at 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Suppression rate of plasma HIV-1 RNA to â?¤200 copies/mL at week 24 and 72Timepoint: Baseline to week 24 and 72 | — |
Countries
India, South Africa
Contacts
Public ContactDr Nishi Suryavanshi
BJMC CTU, B J Govt. Medical College & Sassoon General hospitals Jai Prakash Narayan Road, Pune
Outcome results
None listed