Health Condition 1: null- HIV-1 Infection
Conditions
Interventions
Intervention1: Lopinavir,ritonavir,
Raltegravir,
Emtricitabine,tenofovir, disoproxil fumarate,
Abacavir,lamivudine, zidovudine,
Abacavir,lamivudine,
Lamivudine,zidovudine,
Abacavir,
Zidovudine,
Lamivu
Sponsors
National Institute of Health NIH AIDS Clinical Trials Group
Eligibility
Inclusion criteria
Inclusion criteria: HIV-1 infected Confirmation of first-line virologic failure Certain laboratory values obtained within 45 days prior to study entry, •Negative pregnancy test within 48 hours prior to study entry.
Exclusion criteria
Exclusion criteria: 1 Use of any immunomodulator, HIV vaccine, or other investigational therapy within 45 days prior to study entry, with the exception of a tapering course of corticosteroids as acute therapy for pneumocystis jiroveci pneumonia (PCP) or acute asthma/chronic obstructive pulmonary disease flare and/or prednisone at a daily dose of 10 mg (physiologic replacement dose) 2 If the potential participant has had resistance testing, evidence of broad NRTI cross-resistance that, 3 in the opinion of the investigator, would not allow selection of an effective NRTI combination if the participant were randomized to the LPV/r + best available NRTIs arm 4 Prior exposure to a Protease Inhibitor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether the combination of LPV/r + RAL is associated with virologic efficacy that is non-inferior to that achieved with LPV/r + best-available NRTIs by 48 weeks of follow-up.Timepoint: Time to virologic failure | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Change in CD4+ cell count from baselineTimepoint: Weeks 48 and 96;â?¢Time to first Grade 3 or higher Adverse Event that is at least one grade higher than baselineTimepoint: Through to week 96;HIV-1 drug resistance mutations in gag, protease, reverse transcriptase, and integrase in participants with virologic failure at baseline and at time of virologic failureTimepoint: Through to week 96;To evaluate the safety and tolerability of the study regimensTimepoint: study period | — |
Countries
India, Malawi, South Africa
Contacts
Public ContactDr Nishi Suryavanshi
BJMC CTU
Outcome results
None listed