A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Tenofovir disoproxil fumarate (Drug)
Phase: N/A
Status: Completed
Sponsored by: Gilead Sciences
Summary
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.
Clinical Details
Official title: 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
Study design: Primary Purpose: Treatment
Detailed description:
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Tenofovir Coordinating Center, Foster City, California 94404, United States
Additional Information
Starting date: December 1999
Last updated: June 23, 2005
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