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| Sponsor: | California Collaborative Treatment Group |
|---|---|
| Collaborators: |
California HIV/AIDS Research Program Merck Abbott |
| Information provided by: | California Collaborative Treatment Group |
| ClinicalTrials.gov Identifier: | NCT00752856 |
Purpose
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
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Kaletra + Isentress Drug: Atripla |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2008 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
|
Drug: Atripla
Atripla 1 tab once a day
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory values obtained by screening laboratories within 30 days of entry:
Calculated creatinine clearance (CrCl) > 60 mL/min as estimated by the Cockcroft-Gault equation:
Exclusion Criteria:
Contacts and Locations| 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 | |
| Harbor-UCLA | |
| Torrance, California, United States, 90502 | |
More Information
| Responsible Party: | Miguel Goicoechea, M.D., University California San Diego |
| ClinicalTrials.gov Identifier: | NCT00752856 History of Changes |
| Other Study ID Numbers: | CCTG 589 |
| Study First Received: | September 13, 2008 |
| Last Updated: | September 8, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
HIV treatment Treatment-naive Adult |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir Lopinavir Tenofovir disoproxil Tenofovir |
Efavirenz Emtricitabine Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |