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NCT00002450 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002450
Other study ID # 283D
Secondary ID GS-99-907
Status Completed
Phase Phase 3
First received January 17, 2000
Last updated June 23, 2005

Study information
Verified date July 2000
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tenofovir disoproxil fumarate

Locations
Country Name City State
Puerto Rico Ponce Univ Hosp Ponce
Puerto Rico Clinical Research Puerto Rico Inc San Juan
Puerto Rico San Juan AIDS Program Santurce
United States Albany Med College Albany New York
United States Univ of NM Albuquerque New Mexico
United States Infectious Diseases Physicians Inc Annandale Virginia
United States AIDS Research Consortium of Atlanta Inc Atlanta Georgia
United States Ponce de Leon Med Ctr Atlanta Georgia
United States Dr Joel Gallant Baltimore Maryland
United States Univ of Alabama at Birmingham Birmingham Alabama
United States Massachusetts Gen Hosp Boston Massachusetts
United States New England Med Ctr Boston Massachusetts
United States Bronx Lebanon Hosp Ctr Bronx New York
United States Brookdale Univ Hosp and Med Ctr Brooklyn New York
United States Nalle Clinic / Clinical Research Dept Charlotte North Carolina
United States Northstar Med Clinic Chicago Illinois
United States Ian Baird Columbus Ohio
United States Remington Davis Inc Columbus Ohio
United States Dallas Veterans Administration Med Ctr Dallas Texas
United States Nicholas Bellos Dallas Texas
United States Univ of Colorado / Health Science Ctr Denver Colorado
United States Harper Hosp Detroit Michigan
United States Therafirst Med Ctr Fort Lauderdale Florida
United States ARTCTC Fort Pierce Florida
United States Hampton Roads Med Specialists Hampton Virginia
United States Pennsylvania State College of Medicine Hershey Pennsylvania
United States Thomas Street Clinic Houston Texas
United States Univ of Texas / Thomas Street Clinic Houston Texas
United States Bendel Med Research Lafayette Louisiana
United States Ocean View Internal Medicine Long Beach California
United States St Mary's Med Ctr Long Beach California
United States AIDS Healthcare Foundation-Research Center Los Angeles California
United States Cedars Sinai Med Ctr Los Angeles California
United States Kaiser Permanente LAMC Los Angeles California
United States LAC / USC Med Ctr / Infectious Diseases Los Angeles California
United States Tower Infectious Diseases / Med Associates Inc Los Angeles California
United States Steinhart Medical Associates Miami Florida
United States Univ of Miami School of Medicine Miami Florida
United States Yale New Haven Hosp / Nathan Smith Clinic New Haven Connecticut
United States Yale-New Haven Hospital New Haven Connecticut
United States Columbia Univ New York New York
United States Howard Grossman New York New York
United States St Vincent's Hosp New York New York
United States Robert Scott MD Oakland California
United States Oklahoma Univ Health Science Ctr Oklahoma City Oklahoma
United States Phoenix Body Positive Phoenix Arizona
United States Miriam Hosp / Brown Univ Providence Rhode Island
United States Infections Ltd PS Puyallup Washington
United States Univ of Rochester Medical Center Rochester New York
United States Univ TX San Antonio Health Science Ctr San Antonio Texas
United States UCSD Med Ctr - Owen Clinic San Diego California
United States Kaiser Foundation Hospital San Francisco California
United States Pacific Horizons Med Group San Francisco California
United States San Francisco VA Med Ctr San Francisco California
United States Regions Hosp / HIV/AIDS Program St. Paul Minnesota
United States Infections Ltd / Physicians Med Ctr Tacoma Washington
United States Hillsborough County Health Dept Tampa Florida
United States Harbor UCLA Med Ctr / Research and Educational Institute Torrance California
United States Treasure Coast Infectious Disease Consultants Vero Beach Florida
United States George Washington Univ Med Ctr Washington District of Columbia
United States Physicans Home Service Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Puerto Rico, 

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