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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002415

Enrollment

175

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Drug Therapy, Combination, Prodrugs, Anti-HIV Agents

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.

Interventions

DRUGTenofovir disoproxil fumarate

Study design

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

You may be eligible for this study if you: * Are HIV-positive. * Have an HIV count of 400 - 50,000 copies/ml. * Are expected to live for at least 1 year. * Have been taking the same anti-HIV drug combination (made up of no more than 3 anti-HIV drugs) for at least 8 weeks prior to study entry. * Are at least 18 years old. * Agree to use effective methods of birth control during the study.

Exclusion criteria

You will not be eligible for this study if you: * Have taken medications for certain infections within 15 days prior to study entry. * Have a history of cancer, except Kaposi's sarcoma (KS) or skin cancer. * Develop a new AIDS-related condition within 30 days of study entry. * Have certain serious medical conditions, including severe nausea, vomiting, or other stomach problems that make you unable to take medications by mouth. * Have received a vaccine within 30 days prior to study entry. * Have taken certain medications, including those that may affect your kidneys. * Abuse alcohol or drugs. * Are pregnant.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026