Completed
Tenofovir DF Combination for Stable Antiretroviral Therapy in HIV-1 Patients
Study Aim
This study aims to evaluate the effectiveness of Tenofovir DF combination as a stable antiretroviral therapy in patients diagnosed with HIV-1.
What is being tested
Tenofovir disoproxil fumarate
Drug
Who is being recruted
Blood-Borne Infections+15
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+11 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: December 1999
Summary
Principal SponsorGilead Sciences
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 1999
Actual date on which the first participant was enrolled.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.
Principal SponsorGilead Sciences
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsPathologic ProcessesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesPathological Conditions, Signs and SymptomsVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsDisease AttributesHIV InfectionsDisease Progression
Criteria
6 inclusion criteria required to participate
Agree to use barrier methods of birth control (such as condoms) while on the study and for 30 days afterward
Are HIV-positive
Are at least 18 years old
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.)
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5 exclusion criteria prevent from participating
Abuse alcohol or other substances that your doctor thinks would interfere with taking this medicine
Are pregnant or breast-feeding
Are taking any medicines that interfere with kidney functions
Have a history of a serious kidney or bone disease
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Tenofovir Coordinating Center
Foster City, United StatesOpen Tenofovir Coordinating Center in Google MapsCompletedOne Study Center