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



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

For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Gilead Sciences ,
Synopsis: 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.
Details: Patients take tenofovir DF in combination with other antiretrovirals.
Eligibility:
Study Type:
  Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 

Location and Contact Information:

Dr Gerald Pierone Jr
Vero Beach,  Florida,  32960
United States
 

East Bay AIDS Ctr
Berkeley,  California,  94705
United States
 

Physicans Home Service
Washington D.C.,  District of Columbia,  20037
United States
 

Thomas Street Clinic
Houston,  Texas,  77009
United States
 

Hershey Med Ctr
Hershey,  Pennsylvania,  17033
United States
 

Research & Education Group
Portland,  Oregon,  97209
United States
 

Dr Philip C Craven
Tacoma,  Washington,  98405
United States
 

Roger Williams Med Ctr
Providence,  Rhode Island,  02908
United States
 

Tower ID Med Associates
Los Angeles,  California,  90048
United States
 

Univ of Minnesota
Minneapolis,  Minnesota,  55455
United States
 

Steinhart Medical Associates
Miami,  Florida,  33133
United States
 

Southwest Infectious Diseases Associates
Dallas,  Texas,  75246
United States
 

Anderson Clinical Research
Pittsburgh,  Pennsylvania,  15221
United States
 

Northstar Med Clinic
Chicago,  Illinois,  60657
United States
 

CRI New England
Brookline,  Massachusetts,  02146
United States
 

Harbor - UCLA Med Ctr
Torrance,  California,  90502
United States
 

Univ of Colorado / Health Science Ctr
Denver,  Colorado,  80262
United States
 

Univ of Rochester Med Ctr
Rochester,  New York,  14642
United States
 

Pacific Horizons Med Group
San Francisco,  California,  94115
United States
 


Additional Information:
Study ID Numbers:
  283F;  GS-99-910
Study Start Date: 
Record last reviewed: July 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007436

Other Hiv Infections Studies:
1. A Study of Mitoguazone Dihydrochloride in Patients with AIDS-Related Non-Hodgkin's Lymphoma

2. Phase III PEG-Intron in HIV-infected patients

3. Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients

4. A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment

5. Phase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Antiretroviral Treatment in HIV-Infected Patients with CD4 T-Lymphocyte Count Greater Than 500 Cells/mm3 Who Have Received Antiretroviral Treatment

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