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The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00007436
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
December 19, 2000
August 31, 2001
December 9, 2005
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No Changes Posted
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The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients
A Phase 3, Open-Label, Multicenter Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients
The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at different doses, and may benefit from having tenofovir DF treatment.
Patients take tenofovir DF in combination with other antiretrovirals.
Interventional
Phase 3
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.
 
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Inclusion Criteria

Patients may be eligible for this study if they:

  • Have completed another study on tenofovir DF without toxicity.
  • Are willing to use intrauterine or effective barrier methods of birth control, both men and women, during the study and for 30 days following tenofovir DF treatment.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Are taking drugs that may damage the kidney (nephrotoxic) including aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, vancomycin, and oral or IV ganciclovir.
  • Are taking agents that affect kidney function, such as probenecid.
  • Are receiving systemic chemotherapy.
  • Are taking systemic corticosteroids.
  • Are taking experimental drugs except those that are approved by Gilead.
  • Are currently participating in the GS-99-908 or GS-00-912 (expanded access) studies.
  • Are pregnant or breast-feeding.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00007436
283F
GS-99-910
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Gilead Sciences
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NIH AIDS Clinical Trials Information Service
July 2001

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