Status:
COMPLETED
Mefloquine Prophylaxis in HIV-1 Individuals: a Randomized Placebo-controlled Trial
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This is a randomized placebo controlled trial. Malaria chemoprophylaxis with mefloquine in asymptomatic HIV-infected adults living in a malaria endemic region of Luanshya, Zambia will be compared to a...
Detailed Description
In Zambia prompt treatment of malaria cases is the mainstay of malaria control; antimalarial chemoprophylaxis is not currently recommended for general use so that the use of placebo as a comparator in...
Eligibility Criteria
Inclusion
- Permanent residents of the Luanshya district
- Males and non pregnant adults between 18 and 50 years old.
- Having a CD4 cell count of least 350 perµL at enrolment
- HIV sero-status determined at the VCT of the health center.
- No obvious underlying disease at time of enrolment
- Signed informed consent
Exclusion
- HIV stage III or IV following the WHO classification (see attached documents regarding policy in Zambia)
- Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition, TB).
- Intent to move out of the study catchment area during the study period
- History of allergy to MQ (or related drugs) or sulfa drugs
- Chorionic gonadotrophic hormone in urine or obvious pregnancy
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00373048
Start Date
October 1 2005
End Date
May 1 2011
Last Update
May 24 2011
Active Locations (1)
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1
Tropical Disease Research Center
Ndola, Cupperbelt, Zambia