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



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

For Condition: HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 300

Location and Contact Information:

Tenofovir Coordinating Center
Foster City,  California,  94404
United States
 


Additional Information:
Study ID Numbers:  283C;  GS-99-908
Study Start Date: December 1999
Record last reviewed: May 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002453

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2. Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 Adjuvant

3. The Safety and Effectiveness of HBY 097 Used with or without AZT in HIV-Infected Patients Who Have Mild or No Symptoms

4. A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis carinii Pneumonia.

5. The Effect of Stomach Acid on Foscarnet

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