Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-20 @ 11:37 AM
Study NCT ID:
NCT00065104
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2003-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dehydroepiandrosterone Effects on HIV-1 Replication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'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': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003687', 'term': 'Dehydroepiandrosterone'}], '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': 'D015068', 'term': '17-Ketosteroids'}, {'id': 'D007664', 'term': 'Ketosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-10'}, 'statusVerifiedDate': '2006-08', 'completionDateStruct': {'date': '2003-04'}, 'lastUpdateSubmitDate': '2006-08-16', 'studyFirstSubmitDate': '2003-07-17', 'studyFirstSubmitQcDate': '2003-07-17', 'lastUpdatePostDateStruct': {'date': '2006-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-07-18', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['HIV', 'DHEA', 'immune system', 'hormones', 'body composition', 'quality of life'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': "This study's purpose is to learn how dehydroepiandrosterone (DHEA) affects the HIV virus, the immune system, hormone levels, body composition and quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Evidence of HIV-1 infection\n* HIV RNA \\<50 copies/mL\n* Stable antiretroviral treatment regimen for at least 8 weeks\n* Age 18 years or older\n* Normal pap smear and mammograph within 1 year (females)\n* Normal prostate-specific antigen level with in one year, age adjusted (males)\n\nExclusion criteria:\n\n* Active opportunistic infections or malignancy other than localized cutaneous KS lesions\n* Concurrent or prior use within the past 8 weeks of DHA, testosterone, other anabolic steroids, corticosteroids, megestrol acetate, growth hormone, IL-2, or thalidomide\n* Diagnosis of AIDS Dementia Complex (stage II or higher)\n* Active substance abuse (e.g., alcohol or injection drugs)\n* Evidence of severe liver dysfunction or hepatic transaminases greater than 3x the upper normal limit\n* Pregnant or breast-feeding\n* History of endocrinologically-responsive tumors (e.g., breast, ovarian, uterine, or prostatic cancer, or malignant melanoma)'}, 'identificationModule': {'nctId': 'NCT00065104', 'briefTitle': 'Dehydroepiandrosterone Effects on HIV-1 Replication', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'Dehydroepiandrosterone Effects on HIV-1 Replication', 'orgStudyIdInfo': {'id': 'R01AT000512-01', 'link': 'https://reporter.nih.gov/quickSearch/R01AT000512-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'AbramsD'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'DHEA', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Community Consortium', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}