Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients

Completed · Phase 3

Conditions studied: HIV Infections

In brief

The purpose of this study is to see if giving tenofovir DF plus a combination of other anti-HIV drugs is safe and effective.

Key facts

Study ID

NCT00002450

Run by

Gilead Sciences

People needed

600

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…

• Patients may be eligible for this study if they:
• Are HIV-positive.
• Have been on stable anti-HIV therapy for at least 8 weeks with no more than 4 anti-HIV drugs at the time of study entry.
• Have a viral load (level of HIV in the blood) between 400 and 10,000 copies/ml.
• Have good kidney function.
• Are 18 to 65 years old.
• Agree to use a barrier method of birth control (such as condoms) during the study and for 30 days after.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have a new AIDS-related illness diagnosed within 30 days of study entry.
• Have any other serious medical conditions, including kidney or bone disease, an active infection requiring antibiotics, or cancer (other than Kaposi's sarcoma or certain skin cancers).
• Have received a vaccine within 30 days of study entry.
• Are unable to take medications by mouth.
• Have ever taken tenofovir or adefovir dipivoxil.
• Have taken certain medications within 30 days of study entry, such as chemotherapy, corticosteroids, medications that affect the kidneys, treatment for Kaposi's sarcoma, or certain experimental drugs.
• Abuse alcohol or drugs.
• Are pregnant or breast-feeding.

Where it is running

• Phoenix Body Positive — Phoenix, Arizona, United States
• Ocean View Internal Medicine — Long Beach, California, United States
• St Mary's Med Ctr — Long Beach, California, United States
• AIDS Healthcare Foundation-Research Center — Los Angeles, California, United States
• Kaiser Permanente LAMC — Los Angeles, California, United States
• LAC / USC Med Ctr / Infectious Diseases — Los Angeles, California, United States
• Cedars Sinai Med Ctr — Los Angeles, California, United States
• Tower Infectious Diseases / Med Associates Inc — Los Angeles, California, United States
• Robert Scott MD — Oakland, California, United States
• UCSD Med Ctr - Owen Clinic — San Diego, California, United States
• Pacific Horizons Med Group — San Francisco, California, United States
• Kaiser Foundation Hospital — San Francisco, California, United States
• San Francisco VA Med Ctr — San Francisco, California, United States
• Harbor UCLA Med Ctr / Research and Educational Institute — Torrance, California, United States
• Univ of Colorado / Health Science Ctr — Denver, Colorado, United States
• Yale New Haven Hosp / Nathan Smith Clinic — New Haven, Connecticut, United States
• Yale-New Haven Hospital — New Haven, Connecticut, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• Physicans Home Service — Washington D.C., District of Columbia, United States
• Therafirst Med Ctr — Fort Lauderdale, Florida, United States
• ARTCTC — Ft. Pierce, Florida, United States
• Steinhart Medical Associates — Miami, Florida, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Hillsborough County Health Dept — Tampa, Florida, United States
• Univ of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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