A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
Nandrolone decanoate
Infections transmises par le sang+19
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Body wasting is an increasingly frequent AIDS-defining condition and it is becoming evident that women are not exempt from this complication of HIV. Although multicenter trials of megestrol acetate, dronabinol and growth hormone have not specifically excluded women, women have generally been underrepresented in these trials. This study hopes to generate data that will be substantial enough to perform an analysis that might determine whether there are gender-based differences in anabolic potential. Patients will be randomized to receive either nandrolone decanoate or placebo every 2 weeks for 12 weeks of the study. All patients who complete the first 12 weeks of the study will be eligible to receive open-label nandrolone for the subsequent 12 weeks.
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.38 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.Femme
Le sexe biologique des participants éligibles à s'inscrire.À partir de 13 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 an HIV-positive woman over 13 years old (need consent if under 18). Have lost weight over the past 12 months. Are able to eat almost enough to maintain your current weight. Agree to practice abstinence or use effective methods of birth control. Are on a stable anti-HIV drug regimen or have not been on any anti-HIV drug regimen for the past 30 days. Exclusion Criteria You will not be eligible for this study if you: Are allergic to nandrolone. Have a history of cervical cancer, diabetes, cardiomyopathy or congestive heart failure, or are taking certain medications. Have an active opportunistic (HIV-associated) infection or another major illness within 30 days of study entry. Have an abnormal PAP smear. Have difficulty eating (are on tube-feeding, for example). Have severe nausea, vomiting, or diarrhea. Have Kaposi's sarcoma (unless stable) or are receiving chemotherapy or radiation for any type of cancer. Are pregnant or breast-feeding.
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 22 sites
UCLA CARE Center CRS
Los Angeles, United StatesUcsd, Avrc Crs
San Diego, United StatesUcsf Aids Crs
San Francisco, United States