Clinical trial NCT00002415: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Prodrugs
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham / 1917 Rsch Cln
state: Alabama
city: Phoenix
country: United States
facility: McDowell Clinic
state: Arizona
city: Berkeley
country: United States
facility: East Bay AIDS Ctr
state: California
city: Los Angeles
country: United States
facility: Tower Infectious Disease Med Ctr
state: California
city: San Diego
country: United States
facility: UCSD Treatment Ctr
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Adm Med Cntr
state: California
city: Torrance
country: United States
facility: Harbor UCLA Med Ctr
state: California
city: Denver
country: United States
facility: Univ of Colorado Health Sciences Ctr
state: Colorado
city: Tampa
country: United States
facility: Hillsborough County Health Dept Special Care Ctr
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta Inc
state: Georgia
city: Atlanta
country: United States
facility: Grady Mem Hosp
state: Georgia
city: Atlanta
country: United States
facility: Private Practice / Thacker and Thompson
state: Georgia
city: Chicago
country: United States
facility: Northstar Med Clinic
state: Illinois
city: Brookline
country: United States
facility: CRI New England
state: Massachusetts
city: Minneapolis
country: United States
facility: Univ of Minnesota
state: Minnesota
city: New York
country: United States
facility: Beth Israel Med Ctr
state: New York
city: New York
country: United States
facility: Cornell Clinical Trials Unit - Chelsea Clinic
state: New York
city: Cleveland
country: United States
facility: Univ Hosps of Cleveland
state: Ohio
city: Portland
country: United States
facility: The Research and Education Group
state: Oregon
city: Hershey
country: United States
facility: Hershey Med Ctr
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Anderson Clinical Research
state: Pennsylvania
city: Providence
country: United States
facility: Roger Williams Med Ctr
state: Rhode Island
city: Dallas
country: United States
facility: Amelia Ct Clinic
state: Texas
city: Houston
country: United States
facility: Thomas Street Clinic
state: Texas
Study officials:
References:
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)
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)