HIV Infections Clinical Trial
Official title:
Nucleoside-Sparing Combination Therapy With Lopinavir/Ritonavir (LPV/r) + Raltegravir (RAL) vs. Efavirenz (EFV) + Tenofovir Disoproxil Fumarate + Emtricitabine (TDF/FTC) in Antiretroviral-Naïve Patients
CCTG 589 is a randomized, open-label, pilot study comparing the efficacy, safety and
tolerability of RAL plus LPV/r to EFV plus TDF/FTC in HIV-infected, treatment-naïve subjects.
Subjects will be ineligible if they have any evidence of drug resistant virus in the past or
at the time of screening (if never previously tested). Those who are found to be eligible
will be randomized 1:1 to initiate either LPV/r (400/100 mg) plus RAL (400mg), both given
twice-daily, or fixed dose combination of EFV (600 mg), TDF (300 mg) and FTC (200 mg) given
as once-daily Atripla® for 48 weeks.
Hypotheses
1. The novel nucleoside-sparing combination of LPV/r + RAL will have a faster phase 1 viral
decay rate compared to standard-of-care therapy with EFV/TDF/FTC in antiretroviral-naïve
patients.
1. Faster phase 1 viral decay dynamics will be associated with improved longer-term
(week 48) viral suppression.
2. Faster phase 1 viral decay dynamics will be associated with accelerated early (Day
0-14) clearance of cell-associated HIV DNA.
3. Faster phase 1 viral decay dynamics will be associated with greater early (baseline
to week 12) CD4+ T-cell recovery.
2. The LPV/r + RAL arm will have greater decreases in early (baseline to week 4) CD4/CD8
T-cell immune activation and apoptosis which will be associated with greater late (week
12 to week 48) CD4+ T-cell recovery.
3. Subjects treated with LPV/r + RAL arm will have smaller changes in total cholesterol and
triglycerides from baseline than those receiving EFV/TDF/FTC.
The purpose of this study is to determine how well a new anti-HIV drug combination (RAL plus LPV/r) taken twice a day decreases the amount of HIV found in participants' blood (viral load) compared to taking the once-a-day combination pill Atripla®. This study will also try to determine if the new combination has fewer side effects and is tolerated better than Atripla®. Another reason this study is being done is to see if this new drug combination helps participants' body's CD4 cells recover differently and will also look at how well participants' bodies absorbs these drugs and how safe these drugs are when given together. ;
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