Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-27 @ 4:26 PM
Study NCT ID:
NCT00137657
Status:
COMPLETED
Last Update Posted:
2005-12-13
First Post:
2005-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Cotrimoxazole Prophylaxis for HIV-Infected Adults on Antifolate Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D009894', 'term': 'Opportunistic Infections'}, {'id': 'D004927', 'term': 'Escherichia coli Infections'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015662', 'term': 'Trimethoprim, Sulfamethoxazole Drug Combination'}], 'ancestors': [{'id': 'D013420', 'term': 'Sulfamethoxazole'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014295', 'term': 'Trimethoprim'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'ECT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1478}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-08', 'completionDateStruct': {'date': '2003-11'}, 'lastUpdateSubmitDate': '2005-12-12', 'studyFirstSubmitDate': '2005-08-29', 'studyFirstSubmitQcDate': '2005-08-29', 'lastUpdatePostDateStruct': {'date': '2005-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Plasmodium falciparum molecular markers of antifolate resistance before and while taking daily CTX'}, {'measure': 'Change in nasopharyngeal pneumococcal resistance before and while taking daily CTX, and among children living in households where adults are taking daily CTX'}, {'measure': 'Change in commensal E. coli resistance before and while taking daily CTX'}], 'secondaryOutcomes': [{'measure': 'To measure CTX-resistance among Salmonella and other enteric bacterial pathogens in patients with diarrhea in the study area'}, {'measure': 'To assess the efficacy of sulfadoxine-pyrimethamine (SP) treatment of breakthrough P. falciparum parasitemia and clinical malaria among HIV-infected persons taking daily CTX prophylaxis'}, {'measure': 'To measure sulfa metabolite levels in HIV-infected persons receiving daily CTX who develop a drug reaction, to determine if differing rates of metabolism contribute to the development of adverse reactions'}, {'measure': 'To assess the effect of daily CTX prophylaxis on the etiology of diarrheal diseases in HIV-infected persons'}, {'measure': 'To evaluate the serotype distribution of and immune response to colonizing pneumococci'}, {'measure': 'To assess the cause of diarrheal diseases among HIV-infected persons'}, {'measure': 'To measure the change in quality of life indicators among clients receiving daily CTX'}]}, 'conditionsModule': {'keywords': ['HIV', 'malaria', 'E. Coli', 'S. pneumoniae', 'drug resistance', 'antifolate', 'opportunistic infections', 'Africa', 'Kenya', 'East Africa'], 'conditions': ['HIV', 'Malaria', 'Diarrhea', 'Pneumonia', 'Opportunistic Infections']}, 'descriptionModule': {'briefSummary': 'At least three studies in sub-Saharan Africa have demonstrated a decrease in morbidity or mortality among HIV-infected adults who took daily cotrimoxazole (trimethoprim sulfamethoxazole) \\[CTX\\] prophylaxis. Because of the demonstrated beneficial effect, high tolerability and low cost of CTX, the United Nations Programme on HIV/AIDS (UNAIDS) recommends that HIV-infected persons with symptomatic HIV or depressed CD4 counts receive daily CTX. The effect of this recommendation on subsequent development of antimicrobial resistance to antifolates among important pathogens needs to be evaluated. The investigators measured the change in the prevalence of markers of antifolate resistance among P. falciparum, and the change in the prevalence of CTX resistance among S. pneumoniae, and E. coli in HIV-infected individuals receiving CTX daily prophylaxis. In addition, the investigators measured the change in the prevalence of naso-pharyngeal or oro-pharyngeal carriage of CTX resistant S. pneumoniae among children living in households where an HIV-infected adult was receiving CTX daily prophylaxis.', 'detailedDescription': 'We conducted this study in Kisumu, Kenya where HIV prevalence is high and malaria is highly endemic. HIV infected and uninfected adults were assigned to receive daily CTX if CD4 cell count was \\<350, or daily multivitamin if CD4 cell count was \\>= 350 or if the client was HIV negative. All clients were then followed for a total of 6 months. At specified scheduled and sick visits, clients received a physical exam, blood smears, nasopharyngeal swabs and stool samples or rectal swabs. Samples collected at baseline and during follow-up were used to measure the change in CTX resistance among P. falciparum parasites, pneumococcus isolates, and commensal E. coli.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClients presenting to the CRC HIV counseling and testing site in Kisumu were eligible for the study if they met the following inclusion criteria:\n\n* 15 years of age or older\n* Able to make all follow-up visits (i.e. do not plan to leave Kisumu during the next 6 months, are not homebound)\n* Able to understand and give informed consent.\n\nExclusion Criteria:\n\nClients were not eligible for the study if they met any of the following exclusion criteria:\n\n* Known allergic reaction to sulfa medications (i.e. CTX, sulfadoxine- pyrimethamine)\n* Women in their first trimester of pregnancy or planning to become pregnant in the next 6 months\n* Clients taking daily antibiotics for treatment of a chronic illness; or prophylaxis, excluding tuberculosis treatment.'}, 'identificationModule': {'nctId': 'NCT00137657', 'briefTitle': 'Impact of Cotrimoxazole Prophylaxis for HIV-Infected Adults on Antifolate Resistance', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'An Evaluation of the Impact of Cotrimoxazole Prophylaxis for HIV-Infected Adults on the Development of Antifolate Resistance Among Plasmodium Falciparum, Streptococcus Pneumoniae, and Escherichia Coli', 'orgStudyIdInfo': {'id': 'CDC-NCID-3354'}, 'secondaryIdInfos': [{'id': 'UR6/CCU018970-02-2'}, {'id': 'SSC#664'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Cotrimoxazole (trimethoprim sulfamethoxazole)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kisumu', 'country': 'Kenya', 'facility': 'CDC KEMRI Research Institute', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}], 'overallOfficials': [{'name': 'Mary J Hamel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centers for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, 'collaborators': [{'name': 'Kenya Medical Research Institute', 'class': 'OTHER'}]}}}