A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Antiviral Activity of the Addition of PMPA Prodrug to Combination Antiretroviral Regimens in Treatment-Experienced HIV-Infected Patients

Gilead Sciences24 sites in 1 country175 target enrollmentAugust 31, 2001

ConditionsHIV Infections

DrugsTenofovir disoproxil fumarate

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: HIV Infections
Sponsor: Gilead Sciences
Enrollment: 175
Locations: 24
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 31, 2001

End Date

TBD

Last Updated

20 years ago

Study Type

Interventional

Sex

All