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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00137657
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : December 13, 2005
Kenya Medical Research Institute
Information provided by:
Centers for Disease Control and Prevention

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.

Condition or disease Intervention/treatment Phase
HIV Malaria Diarrhea Pneumonia Opportunistic Infections Drug: Cotrimoxazole (trimethoprim sulfamethoxazole) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1478 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
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
Study Start Date : February 2002
Study Completion Date : November 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Pneumonia

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

Secondary Outcome Measures :
  1. To measure CTX-resistance among Salmonella and other enteric bacterial pathogens in patients with diarrhea in the study area
  2. 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
  3. 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
  4. To assess the effect of daily CTX prophylaxis on the etiology of diarrheal diseases in HIV-infected persons
  5. To evaluate the serotype distribution of and immune response to colonizing pneumococci
  6. To assess the cause of diarrheal diseases among HIV-infected persons
  7. To measure the change in quality of life indicators among clients receiving daily CTX

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00137657

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CDC KEMRI Research Institute
Kisumu, Kenya
Sponsors and Collaborators
Centers for Disease Control and Prevention
Kenya Medical Research Institute
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Principal Investigator: Mary J Hamel, M.D. Centers for Disease Control and Prevention
Layout table for additonal information Identifier: NCT00137657    
Other Study ID Numbers: CDC-NCID-3354
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: December 13, 2005
Last Verified: August 2005
Keywords provided by Centers for Disease Control and Prevention:
E. Coli
S. pneumoniae
drug resistance
opportunistic infections
East Africa
Additional relevant MeSH terms:
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Opportunistic Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Protozoan Infections
Parasitic Diseases
Signs and Symptoms, Digestive
Virus Diseases
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Bacterial Agents