Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients
NCT ID: NCT00002415
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
175 participants
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tenofovir disoproxil fumarate
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Are HIV-positive.
* Have an HIV count of 400 - 50,000 copies/ml.
* Are expected to live for at least 1 year.
* Have been taking the same anti-HIV drug combination (made up of no more than 3 anti-HIV drugs) for at least 8 weeks prior to study entry.
* Are at least 18 years old.
* Agree to use effective methods of birth control during the study.
Exclusion Criteria
* Have taken medications for certain infections within 15 days prior to study entry.
* Have a history of cancer, except Kaposi's sarcoma (KS) or skin cancer.
* Develop a new AIDS-related condition within 30 days of study entry.
* Have certain serious medical conditions, including severe nausea, vomiting, or other stomach problems that make you unable to take medications by mouth.
* Have received a vaccine within 30 days prior to study entry.
* Have taken certain medications, including those that may affect your kidneys.
* Abuse alcohol or drugs.
* Are pregnant.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Univ of Alabama at Birmingham / 1917 Rsch Cln
Birmingham, Alabama, United States
McDowell Clinic
Phoenix, Arizona, United States
East Bay AIDS Ctr
Berkeley, California, United States
Tower Infectious Disease Med Ctr
Los Angeles, California, United States
UCSD Treatment Ctr
San Diego, California, United States
San Francisco Veterans Adm Med Cntr
San Francisco, California, United States
Harbor UCLA Med Ctr
Torrance, California, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Hillsborough County Health Dept Special Care Ctr
Tampa, Florida, United States
AIDS Research Consortium of Atlanta Inc
Atlanta, Georgia, United States
Grady Mem Hosp
Atlanta, Georgia, United States
Private Practice / Thacker and Thompson
Atlanta, Georgia, United States
Northstar Med Clinic
Chicago, Illinois, United States
CRI New England
Brookline, Massachusetts, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
Beth Israel Med Ctr
New York, New York, United States
Cornell Clinical Trials Unit - Chelsea Clinic
New York, New York, United States
Univ Hosps of Cleveland
Cleveland, Ohio, United States
The Research and Education Group
Portland, Oregon, United States
Hershey Med Ctr
Hershey, Pennsylvania, United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, United States
Roger Williams Med Ctr
Providence, Rhode Island, United States
Amelia Ct Clinic
Dallas, Texas, United States
Thomas Street Clinic
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Miller MD, Margot NA, Schooley R, McGowan I. Baseline and week 48 final phenotypic analysis of HIV-1 from patients adding tenofovir disoproxil fumarate (TDF) therapy to background ART. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 441)
Schooley R, Myers R, Ruane R, Beall G, Lampiris H, McGowan I. A double-blind, placebo-controlled study of tenofovir disoproxil fumarate (TDF) for the treatment of HIV infection. 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sep (abstract no I302I)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GS-98-902
Identifier Type: -
Identifier Source: secondary_id
283B
Identifier Type: -
Identifier Source: org_study_id