Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients - Full Text View

Sponsor:	Gilead Sciences
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002415

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Tenofovir disoproxil fumarate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Safety Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

175

Detailed Description:

Prior to study entry patients are stratified according to HIV-1 RNA level, CD4 cell count, and number of antiretroviral drugs. PMPA Prodrug or placebo is added to current antiretroviral regimens, and is administered in one of three dosing regimens. Patients randomized to receive placebo are eligible to receive open-label PMPA Prodrug for the remainder of the 48-week study period after at least 24 weeks post randomization.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002415

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Locations

United States, Alabama
Univ of Alabama at Birmingham / 1917 Rsch Cln
Birmingham, Alabama, United States, 35294
United States, Arizona
McDowell Clinic
Phoenix, Arizona, United States, 85016
United States, California
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
UCSD Treatment Ctr
San Diego, California, United States, 92103
San Francisco Veterans Adm Med Cntr
San Francisco, California, United States, 94121
East Bay AIDS Ctr
Berkeley, California, United States, 94705
Tower Infectious Disease Med Ctr
Los Angeles, California, United States, 90048
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, Florida
Hillsborough County Health Dept Special Care Ctr
Tampa, Florida, United States, 33605
United States, Georgia
Grady Mem Hosp
Atlanta, Georgia, United States, 30308
AIDS Research Consortium of Atlanta Inc
Atlanta, Georgia, United States, 30308
Private Practice / Thacker and Thompson
Atlanta, Georgia, United States, 30324
United States, Illinois
Northstar Med Clinic
Chicago, Illinois, United States, 60657
United States, Massachusetts
CRI New England
Brookline, Massachusetts, United States, 02445
United States, Minnesota
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Cornell Clinical Trials Unit - Chelsea Clinic
New York, New York, United States, 10011
Beth Israel Med Ctr
New York, New York, United States, 10003
United States, Ohio
Univ Hosps of Cleveland
Cleveland, Ohio, United States, 44106
United States, Oregon
The Research and Education Group
Portland, Oregon, United States, 97210
United States, Pennsylvania
Anderson Clinical Research
Pittsburgh, Pennsylvania, United States, 15213
Hershey Med Ctr
Hershey, Pennsylvania, United States, 17033
United States, Rhode Island
Roger Williams Med Ctr
Providence, Rhode Island, United States, 02908
United States, Texas
Amelia Ct Clinic
Dallas, Texas, United States, 75235
Thomas Street Clinic
Houston, Texas, United States, 77009

Sponsors and Collaborators

Gilead Sciences

More Information

Publications:

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)

Study ID Numbers:	283B, GS-98-902
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002415 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination
Prodrugs
Anti-HIV Agents

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil

ClinicalTrials.gov processed this record on November 27, 2009