A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Indinavir sulfate; Drug: Lamivudine; Drug: Stavudine; Drug: Nelfinavir mesylate

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • AIDS Healthcare Foundation
    • Palo Alto, California, United States, 94304
      • Palo Alto Veterans Affairs Health Care System
  • District of Columbia
    • Washington, District of Columbia, United States, 200091104
      • Dupont Circle Physicians Group
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • IDC Research Initiative
    • Fort Lauderdale, Florida, United States, 33316
      • North Broward Hosp District
    • Miami, Florida, United States, 33133
      • Steinhart Medical Associates
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Univ Med School
  • New York
    • New York, New York, United States, 10011
      • Saint Vincents Hosp
    • New York, New York, United States, 10019
      • St Lukes - Roosevelt Hosp Ctr
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • MCP Hahnemann Univ Hosp
  • Texas
    • Dallas, Texas, United States, 75225
      • Southwest Infectious Disease Association / PA
    • Galveston, Texas, United States, 77550
      • Univ TX Galveston Med Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Glaxo Wellcome

Study record dates

Study Major Dates

• Study Start: June 1, 1999

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: August 1, 2000

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Stavudine; Lamivudine; Zidovudine; HIV Protease Inhibitors; Nelfinavir; Drug Administration Schedule; Indinavir; Dosage Forms
• Additional Relevant MeSH Terms: Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Protease Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Lamivudine; Stavudine; Indinavir; Nelfinavir
• Other Study ID Numbers: 225C; COLA 4005