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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tenofovir disoproxil fumarate
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Prodrugs, Anti-HIV Agents

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham / 1917 Rsch Cln
  • McDowell Clinic
  • East Bay AIDS Ctr
  • Tower Infectious Disease Med Ctr
  • UCSD Treatment Ctr
  • San Francisco Veterans Adm Med Cntr
  • Harbor UCLA Med Ctr
  • Univ of Colorado Health Sciences Ctr
  • Hillsborough County Health Dept Special Care Ctr
  • AIDS Research Consortium of Atlanta Inc
  • Grady Mem Hosp
  • Private Practice / Thacker and Thompson
  • Northstar Med Clinic
  • CRI New England
  • Univ of Minnesota
  • Beth Israel Med Ctr
  • Cornell Clinical Trials Unit - Chelsea Clinic
  • Univ Hosps of Cleveland
  • The Research and Education Group
  • Hershey Med Ctr
  • Anderson Clinical Research
  • Roger Williams Med Ctr
  • Amelia Ct Clinic
  • Thomas Street Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00002415
Brief Title
Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gilead Sciences

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Prodrugs, Anti-HIV Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
175 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil fumarate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Univ of Alabama at Birmingham / 1917 Rsch Cln
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
McDowell Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Tower Infectious Disease Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCSD Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Francisco Veterans Adm Med Cntr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Harbor UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Univ of Colorado Health Sciences Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Hillsborough County Health Dept Special Care Ctr
City
Tampa
State/Province
Florida
ZIP/Postal Code
33605
Country
United States
Facility Name
AIDS Research Consortium of Atlanta Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Grady Mem Hosp
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Private Practice / Thacker and Thompson
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30324
Country
United States
Facility Name
Northstar Med Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
CRI New England
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Facility Name
Univ of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Cornell Clinical Trials Unit - Chelsea Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Univ Hosps of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Research and Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Hershey Med Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Anderson Clinical Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Roger Williams Med Ctr
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Amelia Ct Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Thomas Street Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background
Citation
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)
Results Reference
background

Learn more about this trial

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

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