Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT00385632
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2006-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Two Anti-HIV Drug Regimens on Quality of Life and Health Care Use Among SMART Study Participants
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-16', 'studyFirstSubmitDate': '2006-10-06', 'studyFirstSubmitQcDate': '2006-10-06', 'lastUpdatePostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life as assessed by self-administered questionnaires, a symptom severity survey, and an assessment of body appearance', 'timeFrame': 'Throughout study'}, {'measure': 'Self-reported healthcare utilization', 'timeFrame': 'Throughout study'}, {'measure': 'Recorded medications used by participants', 'timeFrame': 'Throughout study'}, {'measure': 'Cost of treating HIV/AIDS', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'keywords': ['Treatment Experienced'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '15344307', 'type': 'BACKGROUND', 'citation': "Anis AH, Guh D, Hogg RS, Wang XH, Yip B, Craib KJ, O'Shaughnessy MV, Schechter MT, Montaner JS. The cost effectiveness of antiretroviral regimens for the treatment of HIV/AIDS. Pharmacoeconomics. 2000 Oct;18(4):393-404. doi: 10.2165/00019053-200018040-00007."}, {'pmid': '16800165', 'type': 'BACKGROUND', 'citation': 'Byrne MW, Honig J. Health-related quality of life of HIV-infected children on complex antiretroviral therapy at home. J Assoc Nurses AIDS Care. 2006 Mar-Apr;17(2):27-35. doi: 10.1016/j.jana.2006.01.003.'}, {'pmid': '16900275', 'type': 'BACKGROUND', 'citation': 'Liu C, Ostrow D, Detels R, Hu Z, Johnson L, Kingsley L, Jacobson LP. Impacts of HIV infection and HAART use on quality of life. Qual Life Res. 2006 Aug;15(6):941-9. doi: 10.1007/s11136-005-5913-x.'}, {'pmid': '16036256', 'type': 'BACKGROUND', 'citation': 'Lowy A, Page J, Jaccard R, Ledergerber B, Somaini B, Weber R, Szucs T. Costs of treatment of Swiss patients with HIV on antiretroviral therapy in hospital-based and general practice-based care: a prospective cohort study. AIDS Care. 2005 Aug;17(6):698-710. doi: 10.1080/09540120412331336689.'}], 'seeAlsoLinks': [{'url': 'http://clinicaltrials.gov/show/NCT00027352', 'label': 'Click here for more information on CPCRA 065'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects of two different anti-HIV drug regimens on quality of life and health care utilization among SMART study participants.', 'detailedDescription': 'Advances in antiretroviral therapy (ART) have dramatically reduced mortality and morbidity rates for HIV infected people. However, HIV infection is a costly disease to treat. With improvement in survival, quality of life and the long-term cost of HIV treatment have become increasingly important to the majority of individuals infected with HIV. Different HIV treatment regimens may lead to variations in quality of life and health care costs over the course of treatment. In the SMART study, participants were randomly assigned to one of two treatment groups:\n\n* Group 1 participants followed a drug conservation (DC) regimen in which ART was stopped or deferred until CD4 cell count dropped below 250 cells/mm3, initiated until CD4 cell count was at least 350 cells/mm3, and then followed by episodic ART based on CD4 cell count.\n* Group 2 participants followed a viral suppression (VS) regimen in which ART was continued to keep viral loads as low as possible, regardless of CD4 cell count.\n\nThe purpose of this study is to compare how the DC and VS regimens affect quality of life, symptom severity, health care utilization, and resulting costs among SMART study participants.\n\nAt baseline, participants will complete questionnaires regarding quality of life, symptoms, health care utilization, current insurance, and socioeconomic status. Body appearance and signs of HIV disease progression will also be assessed at this time. Follow-up evaluations on quality of life and symptoms will be repeated at Months 4, 8, and 12 and annually thereafter. Follow-up evaluations of all other baseline measures will occur once a year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants using conservation and viral suppression ART treatment regimens', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coenrollment in the SMART study\n* Parent or guardian willing to provide informed consent, if applicable'}, 'identificationModule': {'nctId': 'NCT00385632', 'briefTitle': 'Effects of Two Anti-HIV Drug Regimens on Quality of Life and Health Care Use Among SMART Study Participants', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Quality of Life and Healthcare Utilization Substudy', 'orgStudyIdInfo': {'id': 'CPCRA 065A'}, 'secondaryIdInfos': [{'id': 'SMART'}, {'id': '10112', 'type': 'REGISTRY', 'domain': 'DAIDS-ES'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Participants following a drug conservation (DC) regimen in which ART was stopped or deferred until CD4 cell count dropped below 250 cells/mm3, initiated until CD4 cell count was at least 350 cells/mm3, and then followed by episodic ART based on CD4 cell count', 'interventionNames': ['Drug: Antiretroviral Regimens']}, {'label': '2', 'description': 'Participants following a viral suppression (VS) regimen in which ART was continued to keep viral loads as low as possible, regardless of CD4 cell count', 'interventionNames': ['Drug: Antiretroviral Regimens']}], 'interventions': [{'name': 'Antiretroviral Regimens', 'type': 'DRUG', 'description': 'Various antiretroviral therapy combinations already being administered to participants', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93702', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'UCSF, Fresno, School of Medicine, Dept. of Internal Medicine CRS', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '94941-3013', 'city': 'Mill Valley', 'state': 'California', 'country': 'United States', 'facility': 'Dr. M. Estes Med. Practice CRS', 'geoPoint': {'lat': 37.90604, 'lon': -122.54498}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Dr. Robert Scott Med. Practice CRS', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'East Bay AIDS Ctr. CRS', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Dr. Shawn Hassler Med. Practice CRS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94114-1010', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Dr. Virginia Cafaro Med. Practice CRS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94114-1010', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Dr. William Owen Med. Practice CRS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Castro-Mission Health Ctr. CRS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco VAMC, Infectious Diseases Clinic CRS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF PHP, Gen. Internal Medicine Practice CRS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80501-4507', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Beacon Clinic at Boulder CRS', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80204-4507', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Infectious Diseases Consultants CRS', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80204-4507', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Kaiser Permanente of Denver CRS', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80204-4507', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Univ. of Colorado Health Science Ctr. CRS', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Public Health CRS', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80205', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Eastside Family Health Ctr. CRS', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver VAMC CRS', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Public Health CRS - INSIGHT', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Western Infectious Disease Consultants CRS', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Univ. of Connecticut Health Ctr. CRS', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Univ. School of Medicine, NE ProACT - New Haven CRS', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hosp. of St. Raphael CRS', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VAMC West Haven CRS', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}, {'zip': '19947', 'city': 'Georgetown', 'state': 'Delaware', 'country': 'United States', 'facility': 'Georgetown Wellness Clinic', 'geoPoint': {'lat': 38.69011, 'lon': -75.38547}}, {'zip': '19801', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health Services HIV Program CRS', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20422', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami VAMC CRS', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta VAMC CRS', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Klein & Slotten Medical Associates CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cook County Hosp. CORE Ctr.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Univ. of Illinois Family Ctr. for Infectious Disease CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Univ. of Chicago Hosps. CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Lakeshore Infectious Disease Associates CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'North Side Family Medicine CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Physicians Group CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70805', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70808-4390', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'James Osterberger, MD (Private Med. Practice) CRS', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70146', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'New Orleans VAMC CRS', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'CRI-Boston CRS', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'CRI-Springfield CRS', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hosp. CRS', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '39216-4505', 'city': 'Jackson', 'state': 'Michigan', 'country': 'United States', 'facility': 'Univ. of Mississippi Med. Ctr., Div. of Infectious Diseases CRS', 'geoPoint': {'lat': 42.24587, 'lon': -84.40135}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan State Univ., Infectious Disease Clinic CRS', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '48043', 'city': 'Mount Clemens', 'state': 'Michigan', 'country': 'United States', 'facility': 'Mt. Clemens Gen. Hosp. CRS', 'geoPoint': {'lat': 42.59726, 'lon': -82.87798}}, {'zip': '48075', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Providence Hosp,-Newland Med. Assoc Inc CRS', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '08844', 'city': 'Hillsborough', 'state': 'New Jersey', 'country': 'United States', 'facility': 'ID Care Inc. - Hillsborough CRS', 'geoPoint': {'lat': 40.4776, 'lon': -74.62682}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': "Cathedral Healthcare System, St. Michael's Med. Ctr. CRS", 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '07503', 'city': 'Paterson', 'state': 'New Jersey', 'country': 'United States', 'facility': "St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS", 'geoPoint': {'lat': 40.91677, 'lon': -74.17181}}, {'zip': '08861', 'city': 'Perth Amboy', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Raritan Bay Med. Ctr., Perth Amboy Division CRS', 'geoPoint': {'lat': 40.50677, 'lon': -74.26542}}, {'zip': '07869', 'city': 'Randolph Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'ID Care - Randolph CRS', 'geoPoint': {'lat': 40.84829, 'lon': -74.58148}}, {'zip': '07083', 'city': 'Union', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS', 'geoPoint': {'lat': 40.6976, 'lon': -74.2632}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'St. Vincent Hosp. & Med. Ctr. CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Metropolitan Hosp. Ctr. CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10037-1802', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10037', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Harlem Hosp. Ctr., Outpatient Clinics (New York) CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Jacobi Med. Ctr., Ambulatory Care Pavillion CRS', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '77006', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Legacy Community Health Services, Inc. CRS', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine, Thomas St. Clinic CRS', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston AIDS Research Team CRS', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. DeBakey VAMC CRS', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Thomas Street Clinic CRS', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ. Clinical Research Ctr., Memorial Hermann Hosp. CRS', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Veterans Health Care System, Immunosuppression Clinic CRS', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Wafaa El-Sadr, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Harlem AIDS Treatment Group, Harlem Hospital Center'}, {'name': 'James Neaton, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'CPCRA Statistical and Data Management Center/CCBR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Community Programs for Clinical Research on AIDS', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}