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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00011089
First received: February 9, 2001
Last updated: June 23, 2005
Last verified: November 2001

February 9, 2001
June 23, 2005
February 2001
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Complete list of historical versions of study NCT00011089 on ClinicalTrials.gov Archive Site
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Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug Combinations
US Expanded Access Program of Tenofovir Disoproxil Fumarate in the Treatment of HIV-1 Infected Patients Who Have Limited Treatment Options

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.

Patients receive daily doses of tenofovir DF.

Interventional
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Primary Purpose: Treatment
HIV Infections
Drug: Tenofovir disoproxil fumarate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00011089
283G, GS-00-955
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Gilead Sciences
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NIH AIDS Clinical Trials Information Service
November 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP