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
Tenofovir disoproxil fumarate
Infections transmises par le sang+11
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.175 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 65 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 24 sites
Univ of Alabama at Birmingham / 1917 Rsch Cln
Birmingham, United StatesOuvrir Univ of Alabama at Birmingham / 1917 Rsch Cln dans Google MapsMcDowell Clinic
Phoenix, United StatesEast Bay AIDS Ctr
Berkeley, United StatesTower Infectious Disease Med Ctr
Los Angeles, United States