Raltegravir + Lopinavir/Ritonavir Versus Efavirenz + Tenofovir + Emtricitabine in Treatment Naive 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.
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.
- Faster phase 1 viral decay dynamics will be associated with improved longer-term (week 48) viral suppression.
- Faster phase 1 viral decay dynamics will be associated with accelerated early (Day 0-14) clearance of cell-associated HIV DNA.
- Faster phase 1 viral decay dynamics will be associated with greater early (baseline to week 12) CD4+ T-cell recovery.
- 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.
- Subjects treated with LPV/r + RAL arm will have smaller changes in total cholesterol and triglycerides from baseline than those receiving EFV/TDF/FTC.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- To compare the phase 1 viral decay rates between LPV/r + RAL vs. EFV/TDF/FTC treatment combinations. [ Time Frame: 14 days ]
- To determine the antiviral efficacy of LPV/r + RAL compared to EFV/TDF/FTC after 48 weeks of treatment. [ Time Frame: 48 weeks ]
- To compare early (baseline to week 12) and late (week 12 to week 48) CD4+ T-cell recovery rates between treatment regimens. [ Time Frame: 48 weeks ]
- To evaluate the association of phase 1 viral decay dynamics (baseline to day 14) on phase 1 (baseline to week 12) CD4+ T-cell recovery. [ Time Frame: 12 weeks ]
- To evaluate the association of early changes in immune subsets (baseline to week 4) on phase 2 (week 12 to week 48) CD4+ T-cell recovery [ Time Frame: 48 weeks ]
- To evaluate the safety and tolerability of this novel nucleoside-sparing combination of LPV/r + RAL compared to EFV/TDF/FTC therapy [ Time Frame: 48 weeks ]
|Study Start Date:||September 2008|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Kaletra (lopinavir/ritonavir 400/100 mg) + Isentress (Raltegravir 400 mg) twice-daily
Drug: Kaletra + Isentress
kaletra 2 tabs twice a day + Raltegravir 1 tab twice a day
Other Name: lopinavir ritonavir raltegravir
Active Comparator: 2
Sustiva (EFV 600 mg), Viread (TDF 300 mg) and Emtriva (FTC 200 mg) taken as Atripla® once-daily
Atripla 1 tab once a day
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752856
|United States, California|
|Living Hope Clinical Foundation|
|Long Beach, California, United States, 90813|
|University Southern California|
|Los Angeles, California, United States, 90033|
|Univerisity California Irvine|
|Orange, California, United States, 92868|
|Desert AIDS Project|
|Palm Springs, California, United States, 92262|
|University California San Diego|
|San Diego, California, United States, 92103|
|Torrance, California, United States, 90502|