A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Indinavir sulfate (Drug); Nelfinavir mesylate (Drug); Lamivudine (Drug); Stavudine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Glaxo Wellcome
Summary
The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules
(once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either
indinavir (IDV) or nelfinavir (NFV) for 24 weeks.
Clinical Details
Official title: A Phase II, Open-Label, Randomized Study of the Efficacy and Safety of Epivir 150 Mg BID Versus Epivir 300 Mg Once-Daily When Administered for 24 Weeks in Combination With FDA-Approved Dosage Regimens of Zerit and Either Crixivan or Viracept in Subjects With HIV-1 Infection
Study design: Treatment, Open Label, Safety Study
Detailed description:
Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or
NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for
drug tolerance, medication adherence, and genotypic and phenotypic resistance.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
- Are HIV-positive.
- Are at least 18 years old.
- Have had an HIV level below 400 copies/ml for at least 3 months prior to study entry.
- Have a CD4 cell count of at least 50 cells/mm3.
- Are currently taking an anti-HIV drug regimen that includes 3TC plus d4T plus either
IDV or NFV for at least 6 months prior to study entry. (Note: This must be their first
anti-HIV drug regimen.)
- Agree to abstain from sex or use effective methods of birth control during the study.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have a history of an AIDS-defining illness or certain other medical conditions.
- Are allergic to any of the study drugs.
- Are unable to take medication by mouth for any reason.
- Have received certain medications.
- Will need to receive radiation therapy or chemotherapy (for any cancer other than
Kaposi's sarcoma) during the study.
- Are pregnant or breast-feeding.
Locations and Contacts
Palo Alto Veterans Affairs Health Care System, Palo Alto, California 94304, United States
AIDS Healthcare Foundation, Los Angeles, California 90027, United States
Dupont Circle Physicians Group, Washington, District of Columbia 200091104, United States
North Broward Hosp District, Fort Lauderdale, Florida 33316, United States
Steinhart Medical Associates, Miami, Florida 33133, United States
IDC Research Initiative, Altamonte Springs, Florida 32701, United States
Northwestern Univ Med School, Chicago, Illinois 60611, United States
St Lukes - Roosevelt Hosp Ctr, New York, New York 10019, United States
Saint Vincents Hosp, New York, New York 10011, United States
MCP Hahnemann Univ Hosp, Philadelphia, Pennsylvania 19102, United States
Univ TX Galveston Med Branch, Galveston, Texas 77550, United States
Southwest Infectious Disease Association / PA, Dallas, Texas 75225, United States
Additional Information
Starting date: June 1999
Last updated: June 23, 2005
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