Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Antiviral Activity of the Addition of PMPA Prodrug to Combination Antiretroviral Regimens in Treatment-Experienced HIV-Infected Patients
2 other identifiers
interventional
175
1 country
24
Brief Summary
The purpose of this study is to see if it is safe and effective to add PMPA Prodrug (a new anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV drugs in the past. Genetic response will be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- You may be eligible for this study if you:
- 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.
You may not qualify if:
- You will not be eligible for this study if you:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (24)
Univ of Alabama at Birmingham / 1917 Rsch Cln
Birmingham, Alabama, 35294, United States
McDowell Clinic
Phoenix, Arizona, 85016, United States
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Tower Infectious Disease Med Ctr
Los Angeles, California, 90048, United States
UCSD Treatment Ctr
San Diego, California, 92103, United States
San Francisco Veterans Adm Med Cntr
San Francisco, California, 94121, United States
Harbor UCLA Med Ctr
Torrance, California, 90502, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Hillsborough County Health Dept Special Care Ctr
Tampa, Florida, 33605, United States
AIDS Research Consortium of Atlanta Inc
Atlanta, Georgia, 30308, United States
Grady Mem Hosp
Atlanta, Georgia, 30308, United States
Private Practice / Thacker and Thompson
Atlanta, Georgia, 30324, United States
Northstar Med Clinic
Chicago, Illinois, 60657, United States
CRI New England
Brookline, Massachusetts, 02445, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Cornell Clinical Trials Unit - Chelsea Clinic
New York, New York, 10011, United States
Univ Hosps of Cleveland
Cleveland, Ohio, 44106, United States
The Research and Education Group
Portland, Oregon, 97210, United States
Hershey Med Ctr
Hershey, Pennsylvania, 17033, United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213, United States
Roger Williams Med Ctr
Providence, Rhode Island, 02908, United States
Amelia Ct Clinic
Dallas, Texas, 75235, United States
Thomas Street Clinic
Houston, Texas, 77009, United States
Related Publications (2)
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)
BACKGROUNDSchooley 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)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-11