Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-29 @ 4:27 AM
Study NCT ID:
NCT00006158
Status:
COMPLETED
Last Update Posted:
2010-02-15
First Post:
2000-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AIDS Wasting in Women: Anabolic Effects of Testosterone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019247', 'term': 'HIV Wasting Syndrome'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D019282', 'term': 'Wasting Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-12', 'studyFirstSubmitDate': '2000-08-08', 'studyFirstSubmitQcDate': '2000-08-08', 'lastUpdatePostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-08-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['AIDS', 'HIV', 'weight loss', 'Wasting Syndrome', 'testosterone', 'androgen levels', 'hormones'], 'conditions': ['AIDS Wasting Syndrome']}, 'referencesModule': {'references': [{'pmid': '9709937', 'type': 'BACKGROUND', 'citation': 'Miller K, Corcoran C, Armstrong C, Caramelli K, Anderson E, Cotton D, Basgoz N, Hirschhorn L, Tuomala R, Schoenfeld D, Daugherty C, Mazer N, Grinspoon S. Transdermal testosterone administration in women with acquired immunodeficiency syndrome wasting: a pilot study. J Clin Endocrinol Metab. 1998 Aug;83(8):2717-25. doi: 10.1210/jcem.83.8.5051.'}, {'pmid': '10352167', 'type': 'BACKGROUND', 'citation': 'Corcoran C, Grinspoon S. Treatments for wasting in patients with the acquired immunodeficiency syndrome. N Engl J Med. 1999 Jun 3;340(22):1740-50. doi: 10.1056/NEJM199906033402207. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The study is a 6 month, placebo-controlled study of transdermal testosterone for women with HIV-associated weight loss. Women with AIDS wasting have been found to have low testosterone levels. This study is designed to test the efficacy of physiologic testosterone dosing to improve weight, muscle mass and quality of life indices, including energy level, appetite and libido, in androgen deficient women with AIDS wasting. After 6 months, all women receive open label transdermal testosterone for an additional 6 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females using acceptable form of birth control during study, including barrier contraception or IUD but excluding oral contraceptives or Depo-Provera\n* Documented HIV infection\n* Free testosterone level 3.0 pg/mL\n* Weight \\< 90% or weight loss \\> 10% of pre-illness weight\n\nExclusion Criteria:\n\n* Pregnant or actively seeking pregnancy\n* Breast feeding\n* New opportunistic infection diagnosed within 4 weeks of the study\n* Requiring parenteral nutrition or pharmacologic glucocorticoid therapy\n* Intractable diarrhea (6 stools/day)\n* Androgen, estrogen, progestational derivative, or glucocorticoid administration within 3 months of the study, including Megace\n* New retroviral therapy within 6 weeks of study\n* SGOT \\> 5 X normal and/or clinically significant liver disease\n* Creatinine \\> 2.0 mg/dL and/or clinically significant renal disease\n* Hgb \\< 8.0 g/dL\n* Active substance abuse or alcoholism'}, 'identificationModule': {'nctId': 'NCT00006158', 'briefTitle': 'AIDS Wasting in Women: Anabolic Effects of Testosterone', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'orgStudyIdInfo': {'id': 'anabole (completed)'}, 'secondaryIdInfos': [{'id': 'DK54167'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Testosterone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Steven Grinspoon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}}}}