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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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| 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 |
|---|---|
|
1: Experimental
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
|
|
2: Active Comparator
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| Contact: Miguel Goicoechea, M.D. | 619-543-8080 ext 274 | mgoicoechea@ucsd.edu |
| Contact: Kathy Nuffer, RN | 619-543-8080 ext 225 | knuffer@ucsd.edu |
| United States, California | |
| University California San Diego | Recruiting |
| San Diego, California, United States, 92103 | |
| Contact: Miguel Goicoechea, MD 619-543-8080 ext 274 mgoicoechea@ucsd.edu | |
| Contact: Kathy Nuffer, RN 619-543-8080 ext 225 knuffer@ucsd.edu | |
| Principal Investigator: Miguel Goicoechea, MD | |
| Living Hope Clinical Foundation | Recruiting |
| Long Beach, California, United States, 90813 | |
| Contact: Ron Yolo, RN 562-624-4943 ryolo@livinghopefoundation.com | |
| Sub-Investigator: Stephan Schneider, MD | |
| Desert AIDS Project | Recruiting |
| Palm Springs, California, United States, 92262 | |
| Contact: Ivan Womboldt, CCRC 760-320-9505 iwomboldt@mydohc.com | |
| Sub-Investigator: Shubha Kerkar, MD | |
| University Southern California | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Connie Funk, RN 323-343-8282 funk@usc.edu | |
| Contact: Luis Mendez, RN 323-343-8283 lmendez@usc.edu | |
| Sub-Investigator: Michael Dube, MD | |
| Univerisity California Irvine | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Bobi Keenan, RN 714-456-7747 bobki@uci.edu | |
| Sub-Investigator: Jeremiah Tilles, MD | |
| Harbor-UCLA | Recruiting |
| Torrance, California, United States, 90502 | |
| Contact: Angela Grbic, RN 310-222-3848 agrbic@labiomed.org | |
| Principal Investigator: Eric Daar, MD | |
More Information
| Responsible Party: | University California San Diego ( Miguel Goicoechea, M.D. ) |
| Study ID Numbers: | CCTG 589 |
| Study First Received: | September 13, 2008 |
| Last Updated: | September 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00752856 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
HIV treatment Treatment-naive Adult |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Lopinavir Emtricitabine Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil RNA Virus Infections |
HIV Protease Inhibitors Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Ritonavir HIV Infections Sexually Transmitted Diseases Lentivirus Infections |