Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug Combinations

This study is ongoing, but not recruiting participants.

First Received: February 9, 2001 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Gilead Sciences
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00011089

Purpose

The purpose of this study is to make tenofovir disoproxil fumarate (DF) available to HIV-infected patients who have failed other anti-HIV drug combinations, who have few treatment choices available, and whose disease may get worse. This study will allow patients to obtain tenofovir DF before it is approved for marketing.

Condition	Intervention
HIV Infections	Drug: Tenofovir disoproxil fumarate

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	US Expanded Access Program of Tenofovir Disoproxil Fumarate in the Treatment of HIV-1 Infected Patients Who Have Limited Treatment Options

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

Study Start Date:

February 2001

Detailed Description:

Patients receive daily doses of tenofovir DF.

Eligibility

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

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

Are HIV-positive.
Have a viral load (level of HIV in the blood) of at least 10,000 copies/ml by PCR within the previous 2 months.
Have a CD4 count of 100 cells/mm3 or lower within the previous 2 months. Patients with a CD4 count above 100 and as high as 200 cells/mm3 may also be eligible if they had an opportunistic (AIDS-related) infection within the past 90 days.
Have failed treatment with at least 2 protease inhibitors (PIs) or at least 1 PI plus a nonnucleoside reverse transcriptase inhibitor (NNRTI).
Are not able to get effective treatment with a combination of currently approved anti-HIV drugs.
Are at least 18 years old.
Have a negative serum pregnancy test.
Are willing to use a barrier method of birth control (both males and females) while on the study and for 30 days after taking the drug.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have or have had kidney disease or bone disease.
Are pregnant or breast-feeding.
Abuse alcohol or drugs.
Are taking, or have taken within 7 days of enrolling in the study, adefovir dipivoxil or drugs that may cause kidney problems, including aminoglycoside antibiotics, cidofovir, foscarnet, intravenous (IV) amphotericin B, IV pentamidine, IV vancomycin, and chemotherapy (e.g., cisplatin).
Have any medical conditions or have had any medications that the study investigator believes will make him/her unsuitable for the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011089

Locations

United States, California
Medical Information
Foster City, California, United States, 94404

Sponsors and Collaborators

Gilead Sciences

More Information

No publications provided

Study ID Numbers:	283G, GS-00-955
Study First Received:	February 9, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00011089 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Disease Progression
Reverse Transcriptase Inhibitors
Anti-HIV Agents
9-(2-phosphonylmethoxypropyl)adenine

Study placed in the following topic categories:

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:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil

ClinicalTrials.gov processed this record on May 06, 2009