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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002453
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
January 24, 2000
August 31, 2001
December 9, 2005
December 1999
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No Changes Posted
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A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection
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
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.
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.
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.
 
Completed
300
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002453
283C
GS-99-908
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Gilead Sciences
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NIH AIDS Clinical Trials Information Service
May 2000

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