HIVPhase 4NCT00137657
Impact of Cotrimoxazole Prophylaxis for HIV-Infected Adults on Antifolate Resistance
A Phase 4 study testing Cotrimoxazole (trimethoprim sulfamethoxazole) in people with HIV and Malaria, run by Centers for Disease Control and Prevention at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- What is being tested?
- Cotrimoxazole (trimethoprim sulfamethoxazole)
- How many people
- 1,478 participants
- Where
- 1 siteKenya
- Study dates
- Feb 2002to Nov 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- HIV, Malaria, Diarrhea, Pneumonia, Opportunistic Infections
- Being tested
- Cotrimoxazole (trimethoprim sulfamethoxazole)
- Keywords
- HIV, malaria, E. Coli, S. pneumoniae, drug resistance, antifolate, opportunistic infections, Africa, Kenya, East Africa
- Medical subject headings
- Malaria, Diarrhea, Pneumonia, Opportunistic Infections, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cotrimoxazole (trimethoprim sulfamethoxazole)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startFeb 2002
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,478 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Kenya Medical Research Institute
- Investigators
- Mary J Hamel, M.D., Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137657
- Sponsor's protocol ID
- CDC-NCID-3354
- Other IDs
- UR6/CCU018970-02-2, SSC#664
- Status last verified
- Aug 2005
- First submitted
- 29 Aug 2005
- Last updated
- 13 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00137657
- Acronym / sponsor ID
- CDC-NCID-3354
- Conditions
- HIV, Malaria, Diarrhea, Pneumonia, Opportunistic Infections
- Keywords
- HIV, malaria, E. Coli, S. pneumoniae, drug resistance, antifolate, opportunistic infections, Africa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,478 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Kenya Medical Research Institute
- Study start
- Feb 2002
- Study completion
- Nov 2003
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cotrimoxazole (trimethoprim sulfamethoxazole) | Drug | – |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary J Hamel, M.D. principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cotrimoxazole (trimethoprim sulfamethoxazole) in people with HIV and Malaria, run by Centers for Disease Control and Prevention at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasmodium falciparum molecular markers of antifolate resistance before and while taking daily CTX. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2005.