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
Last Update Posted
: April 2, 2014
|
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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
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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 : | 50 participants |
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 |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2010 |

Arm | Intervention/treatment |
---|---|
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
|
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Documented HIV-1 infection.
- Treatment naïve (defined as having never received any HIV antiretroviral agents in past).
- CD4+ T-cell count greater than or equal to 50 cells/mm3
- HIV viral load greater than or equal to 5,000 copies/mL
-
Laboratory values obtained by screening laboratories within 30 days of entry:
- Absolute neutrophil count (ANC) greater than 750/mm3.
- Hemoglobin greater than 8.0 g/dL.
- Platelet count greater than 50,000/mm3.
-
Calculated creatinine clearance (CrCl) > 60 mL/min as estimated by the Cockcroft-Gault equation:
- For men, (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dL x 72) = CrCl (mL/min)
- For women, multiply the result by 0.85 = CrCl (mL/min)
- AST (SGOT), ALT (SGPT), and alkaline phosphatase less than 5 x ULN.
- Total bilirubin less than 2.5 x ULN.
- Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
- Men and women age greater than or equal to 18 years.
- Ability to obtain prescription for HIV antiretroviral medications and to have required prescriptions filled prior to entry.
- Ability and willingness of subject to give written informed consent
Exclusion Criteria:
- Pregnancy or breast-feeding
- Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 30 days prior to study entry (day 0).
- Acute therapy for serious infection or other serious medical illnesses (in the judgment of the site investigator) requiring systemic treatment and/or hospitalization within 14 days prior to study entry (day 0).
- Evidence of HIV seroconversion within 6 months prior to study entry.
- Evidence of any major HIV drug resistance-associated mutation on any genotype performed prior to study entry or at the time of screening.
- History of chronic hepatitis C (defined as HCV antibody positive and HCV RNA detectable).
- History of chronic active hepatitis B (defined as surface antigen positive and/or HBV DNA detectable).
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Use of any immunomodulator, HIV vaccine, or investigational therapy within 30 days of study entry.
- Use of human growth hormone within 30 days prior to study entry.
- Initiation of testosterone or anabolic steroids within 30 days prior to study entry. (Exception: Chronic replacement dosages in patient's with diagnosed hypogonadism is allowed).

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 | |
Harbor-UCLA | |
Torrance, California, United States, 90502 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | California Collaborative Treatment Group |
ClinicalTrials.gov Identifier: | NCT00752856 History of Changes |
Other Study ID Numbers: |
CCTG 589 |
First Posted: | September 16, 2008 Key Record Dates |
Last Update Posted: | April 2, 2014 |
Last Verified: | March 2014 |
Keywords provided by California Collaborative Treatment Group:
HIV treatment Treatment-naive Adult |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Tenofovir Raltegravir Potassium Emtricitabine Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
Efavirenz HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors HIV Integrase Inhibitors Integrase Inhibitors |