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

This study has been completed.

First Received on January 24, 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:	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

Study Type:	Interventional
Study Design:	Primary Purpose: 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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

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:

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00002453 History of Changes
Other Study ID Numbers:	283C, GS-99-908
Study First Received:	January 24, 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
Disease Progression
Anti-HIV Agents

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
Tenofovir disoproxil

Tenofovir
Anti-Retroviral Agents
Reverse Transcriptase Inhibitors
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