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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Tenofovir

Criteria

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.