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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002442

Run by

Glaxo Wellcome

Starts

1999-06-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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