NCT00137657

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,478

participants targeted

Target at P75+ for phase_4 hiv

Timeline
Completed

Started Feb 2002

Shorter than P25 for phase_4 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
Last Updated

December 13, 2005

Status Verified

August 1, 2005

First QC Date

August 29, 2005

Last Update Submit

December 12, 2005

Conditions

HIVMalariaDiarrheaPneumoniaOpportunistic Infections

Keywords

HIVmalariaE. ColiS. pneumoniaedrug resistanceantifolateopportunistic infectionsAfricaKenyaEast Africa

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

Cotrimoxazole (trimethoprim sulfamethoxazole)DRUG

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CDC KEMRI Research Institute

Kisumu, Kenya

Location

MeSH Terms

Conditions

MalariaDiarrheaPneumoniaOpportunistic InfectionsEscherichia coli Infections

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

SulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Mary J Hamel, M.D.

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

February 1, 2002

Study Completion

November 1, 2003

Last Updated

December 13, 2005

Record last verified: 2005-08

Locations

KE(1)