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

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

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:	Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment
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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS HIV/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

Show 24 Study Locations

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)

ClinicalTrials.gov Identifier:	NCT00002415 History of Changes
Other Study ID Numbers:	283B, GS-98-902
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
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:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir disoproxil

Tenofovir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 12, 2012