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

This study has been completed.

First Received: January 24, 2000 Last Updated: June 23, 2005 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: 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

Study ID Numbers:	283C, GS-99-908
Study First Received:	January 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002453 History of Changes
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:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Disease Progression
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors

Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Tenofovir
Retroviridae Infections
Tenofovir disoproxil

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil

RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on September 02, 2009