PMPA Prodrug Addition to Antiretroviral Regimens in Treatment-Experienced HIV-Infected Patients
Tenofovir disoproxil fumarate
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.175 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 24 locations
Univ of Alabama at Birmingham / 1917 Rsch Cln
Birmingham, United StatesOpen Univ of Alabama at Birmingham / 1917 Rsch Cln in Google MapsMcDowell Clinic
Phoenix, United StatesEast Bay AIDS Ctr
Berkeley, United StatesTower Infectious Disease Med Ctr
Los Angeles, United States