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Completed

NCT Number: NCT00137657

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

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.

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Key information

Conditions

HIV Bacterial Infections Bacterial Infections and Mycoses Diarrhea Enterobacteriaceae Infections Escherichia coli Infections Gram-Negative Bacterial Infections Infections Lung Diseases Malaria Mosquito-Borne Diseases Opportunistic Infections Parasitic Diseases Pathological Conditions, Signs and Symptoms Pneumonia Protozoan Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Digestive Vector Borne Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CDC KEMRI Research Institute

Kisumu, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cotrimoxazole (trimethoprim sulfamethoxazole)

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • Kenya Medical Research Institute

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2003
First posted
Aug 30, 2005
Registry last updated
Dec 13, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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