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

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ClinicalTrials.gov Identifier: NCT00137657
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : December 13, 2005
Sponsor:
Collaborator:
Kenya Medical Research Institute
Information provided by:
Centers for Disease Control and Prevention

Tracking Information
First Submitted Date  ICMJE August 29, 2005
First Posted Date  ICMJE August 30, 2005
Last Update Posted Date December 13, 2005
Study Start Date  ICMJE February 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2005)
  • 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
 (submitted: August 29, 2005)
  • 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
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2005)
  • 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
 (submitted: August 29, 2005)
  • 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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Condition  ICMJE
  • HIV
  • Malaria
  • Diarrhea
  • Pneumonia
  • Opportunistic Infections
Intervention  ICMJE Drug: Cotrimoxazole (trimethoprim sulfamethoxazole)
Study Arms  ICMJE 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
 (submitted: August 29, 2005)
1478
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
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
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE 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
PRS Account 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