Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-03-19 @ 6:27 AM
Study NCT ID:
NCT00195234
Status:
COMPLETED
Last Update Posted:
2007-12-05
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Vaccine in Adults With HIV
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-03', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of the HIV CTL MEP vaccine formulated with adjuvants, administered by intramuscular (IM) injection to HIV Pos adults receiving stable HAART. Subjects will receive vaccinations at months 0, 1, 3, and 6.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination.'}]}, 'conditionsModule': {'keywords': ['HIV', 'Treatment Experienced'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn whether the study vaccine and adjuvants (drugs that are used to help improve immune responses) have an acceptable safety profile in treating individuals with HIV.\n\nA second purpose of this study is to understand how the immune system responds to the study vaccine and adjuvants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age diagnosed with HIV and on stable HAART for a minimum of six months\n* CD4 T-cell count greater than and equal to 350/mm3 at screening\n* No reported CD4 T-cell count less than 350/mm3 at any time before screening\n* Viral load less than 50 copies/mL at screening and no viral load greater than 400 copies/mL for a minimum of six months prior to screening\n\nExclusion Criteria:\n\n* Any chronic symptomatic infection other than HIV\n* Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening\n* Any malignancy that may require systemic therapy\n* Use of any investigational treatment within six months before screening or planned during study enrollment, except for investigational retrovirals obtained through ACTG'}, 'identificationModule': {'nctId': 'NCT00195234', 'briefTitle': 'Study Evaluating Vaccine in Adults With HIV', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Phase 1 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of an HIV CTL Multi-Epitope Peptide Vaccine Formulated With RC529-SE and GM-CSF Given to HIV-1 Positive Adults on Stable HAART.', 'orgStudyIdInfo': {'id': '6112K2-100'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HIV CTL MEP 1000 micrograms, 19 months per subject', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44106-5083', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232-2582', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390-9103', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}