The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at different doses, and may benefit from having tenofovir DF treatment.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Tenofovir disoproxil fumarate	Phase III

Further Study Details: 

Patients take tenofovir DF in combination with other antiretrovirals.

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Have completed another study on tenofovir DF without toxicity.
• Are willing to use intrauterine or effective barrier methods of birth control, both men and women, during the study and for 30 days following tenofovir DF treatment.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Are taking drugs that may damage the kidney (nephrotoxic) including aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, vancomycin, and oral or IV ganciclovir.
• Are taking agents that affect kidney function, such as probenecid.
• Are receiving systemic chemotherapy.
• Are taking systemic corticosteroids.
• Are taking experimental drugs except those that are approved by Gilead.
• Are currently participating in the GS-99-908 or GS-00-912 (expanded access) studies.
• Are pregnant or breast-feeding.

California
      Harbor - UCLA Med Ctr, Torrance,  California,  90502,  United States
      Pacific Horizons Med Group, San Francisco,  California,  94115,  United States
      Tower ID Med Associates, Los Angeles,  California,  90048,  United States
      East Bay AIDS Ctr, Berkeley,  California,  94705,  United States
Colorado
      Univ of Colorado / Health Science Ctr, Denver,  Colorado,  80262,  United States
District of Columbia
      Physicans Home Service, Washington,  District of Columbia,  20037,  United States
Florida
      Steinhart Medical Associates, Miami,  Florida,  33133,  United States
      Dr Gerald Pierone Jr, Vero Beach,  Florida,  32960,  United States
Illinois
      Northstar Med Clinic, Chicago,  Illinois,  60657,  United States
Massachusetts
      CRI New England, Brookline,  Massachusetts,  02146,  United States
Minnesota
      Univ of Minnesota, Minneapolis,  Minnesota,  55455,  United States
New York
      Univ of Rochester Med Ctr, Rochester,  New York,  14642,  United States
Oregon
      Research & Education Group, Portland,  Oregon,  97209,  United States
Pennsylvania
      Hershey Med Ctr, Hershey,  Pennsylvania,  17033,  United States
      Anderson Clinical Research, Pittsburgh,  Pennsylvania,  15221,  United States
Rhode Island
      Roger Williams Med Ctr, Providence,  Rhode Island,  02908,  United States
Texas
      Thomas Street Clinic, Houston,  Texas,  77009,  United States
      Southwest Infectious Diseases Associates, Dallas,  Texas,  75246,  United States
Washington
      Dr Philip C Craven, Tacoma,  Washington,  98405,  United States

Study ID Numbers:  283F; GS-99-910
Record last reviewed:  July 2001
Last Updated:  October 13, 2004
Record first received:  December 19, 2000
ClinicalTrials.gov Identifier:  NCT00007436
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08