Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-02-12 @ 3:09 PM
Study NCT ID:
NCT00129532
Status:
UNKNOWN
Last Update Posted:
2005-09-08
First Post:
2005-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of SAVVY and HIV in Ghana
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 2142}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-01'}, 'statusVerifiedDate': '2005-08', 'lastUpdateSubmitDate': '2005-09-07', 'studyFirstSubmitDate': '2005-08-11', 'studyFirstSubmitQcDate': '2005-08-11', 'lastUpdatePostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'combined incidence of HIV-1 and HIV-2'}]}, 'conditionsModule': {'keywords': ['HIV transmission'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '18091987', 'type': 'DERIVED', 'citation': 'Peterson L, Nanda K, Opoku BK, Ampofo WK, Owusu-Amoako M, Boakye AY, Rountree W, Troxler A, Dominik R, Roddy R, Dorflinger L. SAVVY (C31G) gel for prevention of HIV infection in women: a Phase 3, double-blind, randomized, placebo-controlled trial in Ghana. PLoS One. 2007 Dec 19;2(12):e1312. doi: 10.1371/journal.pone.0001312.'}]}, 'descriptionModule': {'briefSummary': 'Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.', 'detailedDescription': 'Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 multi-center, fully-masked, randomized, placebo controlled trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 35 year old women\n* HIV negative\n* More than one sexual partner in past 3 months\n* Average of 3 coital acts per week\n* Willing to use vaginal gel and condoms for 12 months\n\nExclusion Criteria:\n\n* HIV positive\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT00129532', 'briefTitle': 'Trial of SAVVY and HIV in Ghana', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosyn'}, 'officialTitle': 'Randomized Controlled Trial of SAVVY and HIV in Ghana', 'orgStudyIdInfo': {'id': '9779'}}, 'armsInterventionsModule': {'interventions': [{'name': '1.0% C31G SAVVY vaginal gel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Accra', 'country': 'Ghana', 'facility': 'Noguchi Memorial Institute for Medical Research/University of Ghana', 'geoPoint': {'lat': 5.55602, 'lon': -0.1969}}, {'city': 'Kumasi', 'country': 'Ghana', 'facility': 'Komfo Anokye Teaching Hospital/Kwame Nkrumah University of Science and Technology', 'geoPoint': {'lat': 6.68848, 'lon': -1.62443}}], 'overallOfficials': [{'name': 'Leigh Peterson, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'FHI 360'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosyn', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'FHI 360', 'class': 'OTHER'}, {'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}]}}}