Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)
Information source: Abbott
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infection
Intervention: lopinavir/ritonavir (LPV/r) (Drug); emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (Drug); raltegravir (RAL) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Abbott Official(s) and/or principal investigator(s):
Thomas J. Podsadecki, MD, Study Director, Affiliation: Abbott
Overall contact:
Christian T Naylor, BS, Phone: 847-935-2492, Email: christian.naylor@abbott.com
Summary
The purpose of this study is to compare the safety, tolerability and antiviral activity of
the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase
inhibitors to lopinavir/ritonavir tablets when administered in combination with an HIV-1
integrase inhibitor in antiretroviral naive HIV-1 infected subjects.
Clinical Details
Official title: A Randomized, Open-Label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-Formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects
Study design: Treatment, Randomized, Open Label, Parallel Assignment
Primary outcome: Proportion of subjects responding with plasma HIV-1 RNA levels < 40 copies/mL.To compare the safety and tolerability of subjects in each treatment arm.
Secondary outcome: Proportion of subjects with HIV-1 RNA levels < 40 copies/mL at each visit, mean change from baseline in CD4+T cell counts to each visit, time to virologic response, incidence of resistance to each drug in the study regimen.Analysis of patient reported outcomes. Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring. Somatic Toxicity - Full-body DEXA scan and anthropometric measurements for fat redistribution. Metabolic Toxicity - fasted glucose, insulin, lipid measurements (total cholesterol, triglycerides, LDL and HDL), and exploratory markers (lactate, adiponectin, IL-6, leptin, soluble serum TNF receptors I and II.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects must provide written, voluntary informed consent to participate in the
study.
- Subjects must be naive to antiretroviral treatment with HIV RNA greater than or equal
to 1,000 copies/mL at screening, and in the investigator's opinion, require
antiretroviral therapy.
- Subject's vital signs, physical examination and laboratory results do not exhibit
evidence of acute illness.
- Subject has not been treated for an active AIDS-defining opportunistic infection
within 45 days of initiating study drug. Subjects who are on stable maintenance
therapy for an opportunistic infection may be enrolled after consultation with
Sponsor.
- Subject does not require and agrees not to take any drugs that are contraindicated or
have significant pharmacokinetic interactions with study drugs during the course of
the study. Subject agrees not to take any medication during the study, including
over-the-counter medicines, vitamins, minerals, herbal preparations, alcohol or
recreational drugs, without the knowledge and permission of the principal
investigator.
- Female subjects must be either postmenopausal for at least one year, surgically
sterile, or must use a non-hormonal method of birth control that is acceptable to both
the subject and investigator. All female subjects must have a urine pregnancy test
performed at screening visit and on day - 1/baseline, and results of both tests must be
negative. Female subjects may not be breastfeeding.
- Subjects have received no prior treatment with an HIV-1 integrase inhibitor.
Exclusion Criteria:
- Subjects must not have history of an allergic reaction or significant sensitivity to
the study drugs.
- Subjects may not have an ongoing history of substance abuse or psychiatric illness
that could preclude protocol adherence.
- Subject cannot have resistance to lopinavir/ritonavir, tenofovir or emtricitabine
based on the HIV-1 drug resistance genotypic test results at the screening visit.
- Subject may not have significant medical history of concomitant illness or disease
that would adversely affect his/her participating in the study.
- Subjects may not have received any investigational drug or investigational vaccine
within 30 days prior to study drug administration.
- Subjects may not have any of the following abnormal screening results: Hemoglobin <=
8. 0 G/dL, absolute neutrophil count <= 750 cells/mcl/mL, Platelet count <= 50,000 per
mL, ALT (SGPT) or AST (SGOT) >= 3. 0 x upper limit of normal (ULN), calculated
creatinine clearance < 50 mL/min, Hepatitis B surface antigen HBsAG is positive.
- The investigator considers the subject to be an unsuitable candidate for the study.
Locations and Contacts
Christian T Naylor, BS, Phone: 847-935-2492, Email: christian.naylor@abbott.com
Global Medical Information, Abbott Park, Illinois 60064, United States; Recruiting
Phone: 800-633-9110, Email: medinfo@abbott.com
Additional Information
Starting date: July 2008
Last updated: January 28, 2009
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