Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients - Tabular View

Tracking Information
First Received Date ^ICMJE	January 17, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002450 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients
Official Title ^ICMJE	A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Tenofovir Disoproxil Fumarate in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients
Brief Summary	The purpose of this study is to see if giving tenofovir DF plus a combination of other anti-HIV drugs is safe and effective.
Detailed Description	Patients are randomized 2:1 to add tenofovir DF once daily or placebo to their existing antiretroviral regimen in a blinded manner. Patients are stratified according to HIV-1 RNA level, CD4 cell count, and number of antiretroviral drugs taken prior to study entry. Patients and physicians are strongly discouraged from making changes in their antiviral therapies for at least 24 weeks post-randomization. After Week 24, changes in background antiretroviral therapy are permitted. At 24 weeks post-randomization, patients randomized to receive placebo are crossed over to receive open-label tenofovir DF once daily for the remainder of the 48-week study. While on study drug, patients are monitored for safety using periodic physical examinations and serial laboratory tests. Additionally, changes in plasma HIV RNA levels and CD4 cell counts are monitored to assess antiviral efficacy. At the end of the 48-week study period, patients are rolled over into extended dosing until tenofovir DF is commercially available or Gilead Sciences terminates the study.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Tenofovir disoproxil fumarate
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	600
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have been on stable anti-HIV therapy for at least 8 weeks with no more than 4 anti-HIV drugs at the time of study entry. Have a viral load (level of HIV in the blood) between 400 and 10,000 copies/ml. Have good kidney function. Are 18 to 65 years old. Agree to use a barrier method of birth control (such as condoms) during the study and for 30 days after. Exclusion Criteria Patients will not be eligible for this study if they: Have a new AIDS-related illness diagnosed within 30 days of study entry. Have any other serious medical conditions, including kidney or bone disease, an active infection requiring antibiotics, or cancer (other than Kaposi's sarcoma or certain skin cancers). Have received a vaccine within 30 days of study entry. Are unable to take medications by mouth. Have ever taken tenofovir or adefovir dipivoxil. Have taken certain medications within 30 days of study entry, such as chemotherapy, corticosteroids, medications that affect the kidneys, treatment for Kaposi's sarcoma, or certain experimental drugs. Abuse alcohol or drugs. Are pregnant or breast-feeding.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Puerto Rico

Administrative Information
NCT ID ^ICMJE	NCT00002450
Responsible Party
Study ID Numbers ^ICMJE	283D, GS-99-907
Study Sponsor ^ICMJE	Gilead Sciences
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	July 2000
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP