Raltegravir + Lopinavir/Ritonavir Versus Efavirenz + Tenofovir + Emtricitabine in Treatment Naive Patients
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|ClinicalTrials.gov Identifier: NCT00752856|
Recruitment Status : Completed
First Posted : September 16, 2008
Results First Posted : July 7, 2020
Last Update Posted : July 22, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Kaletra + Isentress Drug: Atripla||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 26, 2008|
|Actual Primary Completion Date :||May 5, 2011|
|Actual Study Completion Date :||February 11, 2014|
Experimental: 1 - Kaletra + Isentress taken twice daily
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 (LPV/r) + Raltegravir (RAL)
Active Comparator: 2 - Atripla taken once daily
Sustiva (EFV 600 mg), Viread (TDF 300 mg) and Emtriva (FTC 200 mg) taken as Atripla® once-daily
Atripla 1 tab once a day
Other Name: Efavirenz (EFV) + Tenofovir Disoproxil Fumarate + Emtricitabine (TDF/FTC)
- To Compare the Phase 1 Viral Decay Rates Between LPV/r + RAL vs. EFV/TDF/FTC Treatment Combinations. [ Time Frame: Baseline, days 2, 7, 10, 14 ]Repeated HIV RNA measured at different time points (baseline, days 2, 7, 10, 14) will be treated as the outcome variable in a linear mixed-effects model. The primary fixed effects will include time, treatment group, treatment group-by-time interaction; random effects will include both intercept and slope allowing each subject to have individual baseline viral load and viral decay (rate of decrease in viral load following initiation of antiretroviral therapy). The treatment group-by- time interaction term in the model will indicate the difference in viral decay rates between the two treatment groups. Baseline covariate adjustment will be included if necessary.
- Viral Suppression Efficacy at 48 Weeks [ Time Frame: 48 weeks ]To determine the antiviral efficacy of LPV/r + RAL compared to EFV/TDF/FTC after 48 weeks of treatment by achieving undetectable viral load
- Compare Early Activated CD4+ T-cell Recovery Rates From Baseline to Week 4. [ Time Frame: Baseline to Week 4 ]To compare early (baseline to Week 4) activated CD4+ T-cell recovery rates between treatment regimens.
- Compare Late Activated CD4+ T-cell Recovery Rates Between Treatment Regimens From Baseline to Week 48 [ Time Frame: 48 weeks ]To compare late (baseline to Week 48) activated CD4+ T-cell recovery rates between treatment regimens.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Principal Investigator:||Richard Haubrich, MD||California Collaborative Treatment Group (CCTG)|
|Study Chair:||Sheldon Morris, MD||UC San Diego AntiViral Research Center (AVRC)|