The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2001 by NIH AIDS Clinical Trials Information Service. Recruitment status was Active, not recruiting

First Received on December 19, 2000. Last Updated on June 23, 2005 History of Changes

Sponsor:	Gilead Sciences
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00007436

Purpose

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	Intervention	Phase
HIV Infections	Drug: Tenofovir disoproxil fumarate	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Primary Purpose: Treatment
Official Title:	A Phase 3, Open-Label, Multicenter Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

Patients take tenofovir DF in combination with other antiretrovirals.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007436

Locations

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

Sponsors and Collaborators

Gilead Sciences

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00007436 History of Changes
Other Study ID Numbers:	283F, GS-99-910
Study First Received:	December 19, 2000
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Drug Therapy, Combination
Reverse Transcriptase Inhibitors
Anti-HIV Agents
9-(2-phosphonylmethoxypropyl)adenine

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors

Tenofovir disoproxil
Tenofovir
Anti-Retroviral Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 12, 2012