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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	February 9, 2001
Last Updated Date	June 23, 2005
Start Date ^†	February 2001
Current Primary Outcome Measures ^†
Original Primary Outcome Measures ^†
Change History	Complete list of historical versions of study NCT00011089 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug Combinations
Official Title ^†	US Expanded Access Program of Tenofovir Disoproxil Fumarate in the Treatment of HIV-1 Infected Patients Who Have Limited Treatment Options
Brief Summary	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.
Detailed Description	Patients receive daily doses of tenofovir DF.
Study Phase
Study Type ^†	Interventional
Study Design ^†	Treatment
Condition ^†	HIV Infections
Intervention ^†	Drug: Tenofovir disoproxil fumarate
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Active, not recruiting
Enrollment ^†
Completion Date
Primary Completion Date
Eligibility 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00011089
Responsible Party
Secondary IDs ^††	GS-00-955
Study Sponsor ^†	Gilead Sciences
Collaborators ^††
Investigators ^†
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	November 2001
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.