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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

August 29, 2005
December 12, 2005
February 2002
Not Provided
  • 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
  • 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
Complete list of historical versions of study NCT00137657 on ClinicalTrials.gov Archive Site
  • 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
  • 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.
Not Provided
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Impact of Cotrimoxazole Prophylaxis for HIV-Infected Adults on Antifolate Resistance
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

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
  • HIV
  • Malaria
  • Diarrhea
  • Pneumonia
  • Opportunistic Infections
Drug: Cotrimoxazole (trimethoprim sulfamethoxazole)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1478
November 2003
Not Provided

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.
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT00137657
CDC-NCID-3354, UR6/CCU018970-02-2, SSC#664
Not Provided
Not Provided
Centers for Disease Control and Prevention
Kenya Medical Research Institute
Principal Investigator: Mary J Hamel, M.D. Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
August 2005

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