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

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ClinicalTrials.gov Identifier: NCT00011089
Recruitment Status : Unknown
Verified November 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Tenofovir disoproxil fumarate Not Applicable

Detailed Description:
Patients receive daily doses of tenofovir DF.

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: US Expanded Access Program of Tenofovir Disoproxil Fumarate in the Treatment of HIV-1 Infected Patients Who Have Limited Treatment Options
Study Start Date : February 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00011089


Locations
United States, California
Medical Information
Foster City, California, United States, 94404
Sponsors and Collaborators
Gilead Sciences
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00011089     History of Changes
Other Study ID Numbers: 283G
GS-00-955
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 2001

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Disease Progression
Reverse Transcriptase Inhibitors
Anti-HIV Agents
9-(2-phosphonylmethoxypropyl)adenine

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents