NCT00002453CompletedNot Applicable
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
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gilead Sciences
- Enrollment
- 300
- Locations
- 1
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Not Applicable
Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug CombinationsHIV InfectionsNCT00011089Gilead Sciences
Completed
Phase 3
Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected ChildrenHIV InfectionsNCT00528957Gilead Sciences97
Unknown
Phase 2
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected ChildrenHIV InfectionsNCT00002219Gilead Sciences36
Unknown
Phase 4
TDF Dose Adjustment VS. Switching to TAF in TDF-experienced CHB Patients With Renal ImpairmentTenofovirRenal InsufficiencyNCT04391608Mahidol University80
Completed
Not Applicable
Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug CombinationsHIV InfectionsNCT00002398Gilead Sciences