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

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00002415

Collaborator

(none)

175

Enrollment

Locations

7.3

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Tenofovir disoproxil fumarate	Phase 2

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.

Study Design

Study Type:

Interventional

Masking:

Double

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

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