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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002442
• Other study ID #: 225C
• Secondary ID: COLA 4005
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005
• Start date: June 1999

Study information

• Verified date: August 2000
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Nelfinavir mesylate

• Lamivudine

• Stavudine

Locations

Country	Name	City	State
United States	IDC Research Initiative	Altamonte Springs	Florida
United States	Northwestern Univ Med School	Chicago	Illinois
United States	Southwest Infectious Disease Association / PA	Dallas	Texas
United States	North Broward Hosp District	Fort Lauderdale	Florida
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	AIDS Healthcare Foundation	Los Angeles	California
United States	Steinhart Medical Associates	Miami	Florida
United States	Saint Vincents Hosp	New York	New York
United States	St Lukes - Roosevelt Hosp Ctr	New York	New York
United States	Palo Alto Veterans Affairs Health Care System	Palo Alto	California
United States	MCP Hahnemann Univ Hosp	Philadelphia	Pennsylvania
United States	Dupont Circle Physicians Group	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,