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Clinical Trial Name -A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
| Original Study ID : ACTG 329 |
| NCT ID : NCT00000854 |
| Brief Title : A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss |
| Official Title : A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss |
| Brief Summary : The purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will cause weight gain in HIV-positive women who have HIV-associated weight loss (wasting). Wasting has become an AIDS-defining condition. In the past, most studies that examined wasting treatments were limited to men. However, it appears that wasting in HIV-positive men is linked to levels of testosterone (a hormone which affects men's bodies more than women's). This study has been designed for women only, in order to best treat wasting in HIV-positive women. |
| Source : National Institute of Allergy and Infectious Diseases (NIAID) |
| Detailed Description : 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. |
| Overall Status : Completed |
| Start Date : December 1996 |
| Official Title : Phase 1 |
| Phase : Interventional |
| Study Design : Treatment, Parallel Assignment, Safety Study |
| Enrollment : 38 |
| Verification Date : May 2005 |
| First Received Date : November 2, 1999 |
| Trial Eligibility |
| Criteria : 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. |
| Gender : Female |
| Minimum Age : 13 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Univ of California / San Diego Treatment Ctr |
| City : San Diego |
| State : California |
| Zip Code : 921036325 |
| Country : United States |
| Facility Name : San Francisco Gen Hosp |
| City : San Francisco |
| State : California |
| Zip Code : 941102859 |
| Country : United States |
| Facility Name : UCLA CARE Ctr |
| City : Los Angeles |
| State : California |
| Zip Code : 90095 |
| Country : United States |
| Facility Name : Univ of Southern California / LA County USC Med Ctr |
| City : Los Angeles |
| State : California |
| Zip Code : 900331079 |
| Country : United States |
| Facility Name : Univ of Colorado Health Sciences Ctr |
| City : Denver |
| State : Colorado |
| Zip Code : 80262 |
| Country : United States |
| Facility Name : Howard Univ |
| City : Washington |
| State : District of Columbia |
| Zip Code : 20059 |
| Country : United States |
| Facility Name : Queens Med Ctr |
| City : Honolulu |
| State : Hawaii |
| Zip Code : 96816 |
| Country : United States |
| Facility Name : Univ of Hawaii |
| City : Honolulu |
| State : Hawaii |
| Zip Code : 96816 |
| Country : United States |
| Facility Name : Northwestern Univ Med School |
| City : Chicago |
| State : Illinois |
| Zip Code : 60611 |
| Country : United States |
| Facility Name : Charity Hosp / Tulane Univ Med School |
| City : New Orleans |
| State : Louisiana |
| Zip Code : 70112 |
| Country : United States |
| Facility Name : Johns Hopkins Hosp |
| City : Baltimore |
| State : Maryland |
| Zip Code : 21287 |
| Country : United States |
| Facility Name : Beth Israel Deaconess - West Campus |
| City : Boston |
| State : Massachusetts |
| Zip Code : 02215 |
| Country : United States |
| Facility Name : St Louis Regional Hosp / St Louis Regional Med Ctr |
| City : St. Louis |
| State : Missouri |
| Zip Code : 63112 |
| Country : United States |
| Facility Name : Univ of Rochester Medical Center |
| City : Rochester |
| State : New York |
| Zip Code : 14642 |
| Country : United States |
| Facility Name : Beth Israel Med Ctr |
| City : New York |
| State : New York |
| Zip Code : 10003 |
| Country : United States |
| Facility Name : Univ of North Carolina |
| City : Chapel Hill |
| State : North Carolina |
| Zip Code : 275997215 |
| Country : United States |
| Facility Name : Duke Univ Med Ctr |
| City : Durham |
| State : North Carolina |
| Zip Code : 27710 |
| Country : United States |
| Facility Name : Univ of Cincinnati |
| City : Cincinnati |
| State : Ohio |
| Zip Code : 452670405 |
| Country : United States |
| Facility Name : Univ of Pennsylvania at Philadelphia |
| City : Philadelphia |
| State : Pennsylvania |
| Zip Code : 19104 |
| Country : United States |
| Facility Name : Julio Arroyo |
| City : West Columbia |
| State : South Carolina |
| Zip Code : 29169 |
| Country : United States |
| Facility Name : Univ of Puerto Rico |
| City : San Juan |
| State : South Carolina |
| Zip Code : 009365067 |
| Country : Puerto Rico |
| Refferances |
| Citation : Mulligan K, Zackin R, Clark RA, Sattler FR, Santana J, Delvers T, Currier JS. Nandrolone decanoate increases weight and lean body mass in HIV-infected women with weight loss: a randomized, double-blind, placebo-controlled, multicenter trial. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 641) |
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