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

This study has been completed.

Sponsor:

Collaborator:

Kenya Medical Research Institute

Information provided by:

Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier:

NCT00137657

First received: August 29, 2005

Last updated: December 12, 2005

Last verified: August 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

August 29, 2005

Last Updated Date

December 12, 2005

Start Date ^ICMJE

February 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Change in Plasmodium falciparum molecular markers of antifolate resistance before and while taking daily CTX
Change in nasopharyngeal pneumococcal resistance before and while taking daily CTX, and among children living in households where adults are taking daily CTX
Change in commensal E. coli resistance before and while taking daily CTX

Original Primary Outcome Measures ^ICMJE

Change in Plasomdium falciparum molecular markers of antifolate resistance before and while taking daily CTX
Change in nasopharyngeal pneumococcal resistance before and while taking daily CTX, and among children living in household where adults are taking daily CTX.
Change in commensal E. coli resistance before and while taking daily CTX

Change History

Complete list of historical versions of study NCT00137657 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To measure CTX-resistance among Salmonella and other enteric bacterial pathogens in patients with diarrhea in the study area
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
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
To assess the effect of daily CTX prophylaxis on the etiology of diarrheal diseases in HIV-infected persons
To evaluate the serotype distribution of and immune response to colonizing pneumococci
To assess the cause of diarrheal diseases among HIV-infected persons
To measure the change in quality of life indicators among clients receiving daily CTX

Original Secondary Outcome Measures ^ICMJE

To measure CTX-resistance among Salmonella and other enteric bacterial pathogens in patients with diarrhea in the study area.
To assess the efficacy of SP treatment of breakthrough P. falciparum parasitemia and clinical malaria among HIV infected persons taking daily CTX prophylaxis
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.
To assess the effect of daily CTX prophylaxis on the etiology of diarrheal diseases in HIV infected persons
To evaluate the serotype distribution of and immune response to colonizing pneumococci
To assess the cause of diarrheal diseases among HIV infected persons.
To measure the change in quality of life indicators among clients receiving daily CTX.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training

Condition ^ICMJE

HIV
Malaria
Diarrhea
Pneumonia
Opportunistic Infections

Intervention ^ICMJE

Drug: Cotrimoxazole (trimethoprim sulfamethoxazole)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1478

Completion Date

November 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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:

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:

Clients were not eligible for the study if they met any of the following 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.

Gender

Both

Ages

15 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Kenya

Administrative Information

NCT Number ^ICMJE

NCT00137657

Other Study ID Numbers ^ICMJE

CDC-NCID-3354, UR6/CCU018970-02-2, SSC#664

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Centers for Disease Control and Prevention

Collaborators ^ICMJE

Kenya Medical Research Institute

Investigators ^ICMJE

Principal Investigator:

Mary J Hamel, M.D.

Centers for Disease Control and Prevention

Information Provided By

Centers for Disease Control and Prevention

Verification Date

August 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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