Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002415
• Lead Sponsor: Gilead Sciences

Brief Summary

The purpose of this study is to see if it is safe and effective to add PMPA Prodrug (a new anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV drugs in the past. Genetic response will be studied.

Detailed Description

Prior to study entry patients are stratified according to HIV-1 RNA level, CD4 cell count, and number of antiretroviral drugs. PMPA Prodrug or placebo is added to current antiretroviral regimens, and is administered in one of three dosing regimens. Patients randomized to receive placebo are eligible to receive open-label PMPA Prodrug for the remainder of the 48-week study period after at least 24 weeks post randomization.

Study Timeline

• Status Verified: 1999-11
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (24)

Univ of Alabama at Birmingham / 1917 Rsch Cln; 🇺🇸 Birmingham, Alabama, United States

McDowell Clinic; 🇺🇸 Phoenix, Arizona, United States

East Bay AIDS Ctr; 🇺🇸 Berkeley, California, United States

Tower Infectious Disease Med Ctr; 🇺🇸 Los Angeles, California, United States

UCSD Treatment Ctr; 🇺🇸 San Diego, California, United States

San Francisco Veterans Adm Med Cntr; 🇺🇸 San Francisco, California, United States

Harbor UCLA Med Ctr; 🇺🇸 Torrance, California, United States

Univ of Colorado Health Sciences Ctr; 🇺🇸 Denver, Colorado, United States

Hillsborough County Health Dept Special Care Ctr; 🇺🇸 Tampa, Florida, United States

AIDS Research Consortium of Atlanta Inc; 🇺🇸 Atlanta, Georgia, United States

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