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Sponsors and Collaborators: |
Centers for Disease Control and Prevention Kenya Medical Research Institute |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00137657 |
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.
Condition | Intervention | Phase |
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HIV Malaria Diarrhea Pneumonia Opportunistic Infections |
Drug: Cotrimoxazole (trimethoprim sulfamethoxazole) |
Phase IV |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | 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 |
Estimated Enrollment: | 1478 |
Study Start Date: | February 2002 |
Estimated Study Completion Date: | November 2003 |
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.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clients presenting to the CRC HIV counseling and testing site in Kisumu were eligible for the study if they met the following inclusion criteria:
Exclusion Criteria:
Clients were not eligible for the study if they met any of the following exclusion criteria:
Study ID Numbers: | CDC-NCID-3354, UR6/CCU018970-02-2, SSC#664 |
Study First Received: | August 29, 2005 |
Last Updated: | December 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00137657 |
Health Authority: | United States: Federal Government |
HIV malaria E. Coli S. pneumoniae drug resistance |
antifolate opportunistic infections Africa Kenya East Africa |
Opportunistic Infections Protozoan Infections Trimethoprim Diarrhea Sulfamethoxazole Acquired Immunodeficiency Syndrome Trimethoprim-Sulfamethoxazole Combination Malaria |
Folic Acid Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections HIV Infections Lung Diseases Parasitic Diseases Pneumonia |
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Anti-Infective Agents, Urinary Enzyme Inhibitors Infection |
Renal Agents Folic Acid Antagonists Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses |