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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002415
• Other study ID #: 283B
• Secondary ID: GS-98-902
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Tenofovir disoproxil fumarate

Locations

Country	Name	City	State
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	East Bay AIDS Ctr	Berkeley	California
United States	Univ of Alabama at Birmingham / 1917 Rsch Cln	Birmingham	Alabama
United States	CRI New England	Brookline	Massachusetts
United States	Northstar Med Clinic	Chicago	Illinois
United States	Univ Hosps of Cleveland	Cleveland	Ohio
United States	Amelia Ct Clinic	Dallas	Texas
United States	Univ of Colorado Health Sciences Ctr	Denver	Colorado
United States	Hershey Med Ctr	Hershey	Pennsylvania
United States	Thomas Street Clinic	Houston	Texas
United States	Tower Infectious Disease Med Ctr	Los Angeles	California
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	McDowell Clinic	Phoenix	Arizona
United States	Anderson Clinical Research	Pittsburgh	Pennsylvania
United States	The Research and Education Group	Portland	Oregon
United States	Roger Williams Med Ctr	Providence	Rhode Island
United States	UCSD Treatment Ctr	San Diego	California
United States	San Francisco Veterans Adm Med Cntr	San Francisco	California
United States	Hillsborough County Health Dept Special Care Ctr	Tampa	Florida
United States	Harbor UCLA Med Ctr	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

References & 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)

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)