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 because the information has not been verified recently.
Verified July 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:
NCT00007436
First received: December 19, 2000
Last updated: June 23, 2005
Last verified: July 2001

December 19, 2000
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00007436 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
Drug: Tenofovir disoproxil fumarate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
Not Provided
Not Provided
Not Provided

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00007436
283F, GS-99-910
Not Provided
Not Provided
Gilead Sciences
Not Provided
Not Provided
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