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

June 23, 2005 updated by: Gilead Sciences

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

The purpose of this study is to see if giving tenofovir DF plus a combination of other anti-HIV drugs is safe and effective.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00731
        • Ponce Univ Hosp
      • San Juan, Puerto Rico, 009091711
        • Clinical Research Puerto Rico Inc
      • Santurce, Puerto Rico, 00908
        • San Juan AIDS Program
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Body Positive
    • California
      • Long Beach, California, United States, 90803
        • Ocean View Internal Medicine
      • Long Beach, California, United States, 90813
        • St Mary's Med Ctr
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente LAMC
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Med Ctr
      • Los Angeles, California, United States, 90033
        • LAC / USC Med Ctr / Infectious Diseases
      • Los Angeles, California, United States, 90048
        • Tower Infectious Diseases / Med Associates Inc
      • Los Angeles, California, United States, 90027
        • AIDS Healthcare Foundation-Research Center
      • Oakland, California, United States, 94609
        • Robert Scott MD
      • San Diego, California, United States, 921038681
        • UCSD Med Ctr - Owen Clinic
      • San Francisco, California, United States, 94115
        • Pacific Horizons Med Group
      • San Francisco, California, United States, 94121
        • San Francisco VA Med Ctr
      • San Francisco, California, United States, 94118
        • Kaiser Foundation Hospital
      • Torrance, California, United States, 90502
        • Harbor UCLA Med Ctr / Research and Educational Institute
    • Colorado
      • Denver, Colorado, United States, 80262
        • Univ of Colorado / Health Science Ctr
    • Connecticut
      • New Haven, Connecticut, United States, 06504
        • Yale-New Haven Hospital
      • New Haven, Connecticut, United States, 06504
        • Yale New Haven Hosp / Nathan Smith Clinic
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ Med Ctr
      • Washington, District of Columbia, United States, 20037
        • Physicans Home Service
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Therafirst Med Ctr
      • Fort Pierce, Florida, United States, 34950
        • ARTCTC
      • Miami, Florida, United States, 33136
        • Univ of Miami School of Medicine
      • Miami, Florida, United States, 33133
        • Steinhart Medical Associates
      • Tampa, Florida, United States, 33602
        • Hillsborough County Health Dept
      • Vero Beach, Florida, United States, 32960
        • Treasure Coast Infectious Disease Consultants
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta Inc
      • Atlanta, Georgia, United States, 30308
        • Ponce de Leon Med Ctr
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Northstar Med Clinic
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Bendel Med Research
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Dr Joel Gallant
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Med Ctr
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Gen Hosp
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Harper Hosp
    • Minnesota
      • St. Paul, Minnesota, United States, 55101
        • Regions Hosp / HIV/AIDS Program
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Univ of NM
    • New York
      • Albany, New York, United States, 12208
        • Albany Med College
      • Bronx, New York, United States, 10457
        • Bronx Lebanon Hosp Ctr
      • Brooklyn, New York, United States, 112123198
        • Brookdale Univ Hosp and Med Ctr
      • New York, New York, United States, 10011
        • Howard Grossman
      • New York, New York, United States, 10032
        • Columbia Univ
      • New York, New York, United States, 10011
        • St Vincent's Hosp
      • Rochester, New York, United States, 14642
        • Univ of Rochester Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Nalle Clinic / Clinical Research Dept
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Remington Davis Inc
      • Columbus, Ohio, United States, 43214
        • Ian Baird
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Univ Health Science Ctr
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Pennsylvania State College of Medicine
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hosp / Brown Univ
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas Veterans Administration Med Ctr
      • Dallas, Texas, United States, 75246
        • Nicholas Bellos
      • Houston, Texas, United States, 77009
        • Thomas Street Clinic
      • Houston, Texas, United States, 77030
        • Univ of Texas / Thomas Street Clinic
      • San Antonio, Texas, United States, 78284
        • Univ TX San Antonio Health Science Ctr
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Infectious Diseases Physicians Inc
      • Hampton, Virginia, United States, 23666
        • Hampton Roads Med Specialists
    • Washington
      • Puyallup, Washington, United States, 98371
        • Infections Ltd PS
      • Tacoma, Washington, United States, 98405
        • Infections Ltd / Physicians Med Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2000

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2001

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 283D
  • GS-99-907

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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