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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002415

Run by

Gilead Sciences

People needed

175

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Grady Mem Hosp — Atlanta, Georgia, United States
• Private Practice / Thacker and Thompson — Atlanta, Georgia, United States
• Northstar Med Clinic — Chicago, Illinois, United States
• CRI New England — Brookline, Massachusetts, United States
• Univ of Minnesota — Minneapolis, Minnesota, United States
• Beth Israel Med Ctr — New York, New York, United States
• Cornell Clinical Trials Unit - Chelsea Clinic — New York, New York, United States
• Univ Hosps of Cleveland — Cleveland, Ohio, United States
• The Research and Education Group — Portland, Oregon, United States
• Hershey Med Ctr — Hershey, Pennsylvania, United States
• Anderson Clinical Research — Pittsburgh, Pennsylvania, United States
• Roger Williams Med Ctr — Providence, Rhode Island, United States
• Amelia Ct Clinic — Dallas, Texas, United States
• Thomas Street Clinic — Houston, Texas, United States

Full record on ClinicalTrials.gov

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