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

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

MedlinePlus related topics:

AIDS AIDS Medicines

ChemIDplus related topics:

Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Adenine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety Study

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

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
	Harbor - UCLA Med Ctr
	Torrance, California, United States, 90502
	Pacific Horizons Med Group
	San Francisco, California, United States, 94115
	Tower ID Med Associates
	Los Angeles, California, United States, 90048
	East Bay AIDS Ctr
	Berkeley, California, United States, 94705

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
	Thomas Street Clinic
	Houston, Texas, United States, 77009
	Southwest Infectious Diseases Associates
	Dallas, Texas, United States, 75246

United States, Washington
	Dr Philip C Craven
	Tacoma, Washington, United States, 98405

Sponsors and Collaborators

Gilead Sciences

More Information

Study ID Numbers:	283F, GS-99-910
First Received:	December 19, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00007436
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

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Tenofovir

Retroviridae Infections

Immunologic Deficiency Syndromes

Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 10, 2008

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