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Impact of Cotrimoxazole Prophylaxis for HIV-Infected Adults on Antifolate Resistance

NCT ID: NCT00137657

Last Updated: 2005-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1478 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2003-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Malaria Diarrhea Pneumonia Opportunistic Infections

Keywords

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HIV malaria E. Coli S. pneumoniae drug resistance antifolate opportunistic infections Africa Kenya East Africa

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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Cotrimoxazole (trimethoprim sulfamethoxazole)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 15 years of age or older
* Able to make all follow-up visits (i.e. do not plan to leave Kisumu during the next 6 months, are not homebound)
* Able to understand and give informed consent.

Exclusion Criteria

* Known allergic reaction to sulfa medications (i.e. CTX, sulfadoxine- pyrimethamine)
* Women in their first trimester of pregnancy or planning to become pregnant in the next 6 months
* Clients taking daily antibiotics for treatment of a chronic illness; or prophylaxis, excluding tuberculosis treatment.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kenya Medical Research Institute

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Principal Investigators

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Mary J Hamel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Locations

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CDC KEMRI Research Institute

Kisumu, , Kenya

Site Status

Countries

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Kenya

Other Identifiers

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UR6/CCU018970-02-2

Identifier Type: -

Identifier Source: secondary_id

SSC#664

Identifier Type: -

Identifier Source: secondary_id

CDC-NCID-3354

Identifier Type: -

Identifier Source: org_study_id