Clinical trial NCT00002450: Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
Drug Administration Schedule
RNA, Viral
Anti-HIV Agents
Viral Load
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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