A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection - Full Text View

A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection

This study has been completed.

Sponsored by:	Gilead Sciences
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002453

Purpose

This study allows patients who need a new anti-HIV treatment to take tenofovir disoproxil fumarate (tenofovir DF), an experimental drug. This study also looks at any side effects the drug causes.

Condition	Intervention
HIV Infections	Drug: Tenofovir disoproxil fumarate

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Official Title:	An Open-Label, Multicenter, Compassionate Access 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:

Estimated Enrollment:	300
Study Start Date:	December 1999

Detailed Description:

HIV-1-infected patients who are currently receiving stable antiretroviral therapy add tenofovir DF to their regimen. Study participation lasts for approximately 48 weeks. Interested patients should contact their physicians.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

You may be eligible for this study if you:

Are HIV-positive.
Have a viral load greater than or equal to 10,000 copies/ml.
Have a CD4 count less than or equal to 50 cells/mm3, or have a CD4 count greater than 50 and no more than 200 cells/mm3 with an opportunistic (AIDS-related) infection within 90 days of study entry. (Patients with a CD4 count above 200 cells/mm3 may be considered depending on drug supply.)
Are at least 18 years old.
Agree to use barrier methods of birth control (such as condoms) while on the study and for 30 days afterward.
Have a life expectancy of at least one year.

Exclusion Criteria

You will not be eligible for this study if you:

Have a history of a serious kidney or bone disease.
Have severe nausea, vomiting, or trouble taking medications by mouth.
Are pregnant or breast-feeding.
Abuse alcohol or other substances that your doctor thinks would interfere with taking this medicine.
Are taking any medicines that interfere with kidney functions.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002453

Locations


United States, California
	Tenofovir Coordinating Center
	Foster City, California, United States, 94404

Sponsors and Collaborators

Gilead Sciences

More Information

Study ID Numbers:	283C, GS-99-908
First Received:	January 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002453
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1

Drug Therapy, Combination

Disease Progression

Anti-HIV Agents

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Disease Progression

Tenofovir

Retroviridae Infections

Immunologic Deficiency Syndromes

Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents

Communicable Diseases

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