Mefloquine Prophylaxis in HIV-1 Individuals: a Randomized Placebo-controlled Trial

Institute of Tropical Medicine, Belgium

Status

Completed

Conditions

HIV Infections

Treatments

Drug: placebo

Drug: mefloquine

Study type

Interventional

Funder types

Other

Identifiers

NCT00373048

Mefloquine HIV zambia

Details and patient eligibility

About

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 placebo control group and followed up for 18 months.

Full 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 this study is justified. We will analyse safety and efficacy of mefloquine, malaria and AIDS related parameters at predefined time points, and verify if this intervention could produce a slower decrease in CD4 counts compared to passive case management of malaria.

Specific designed studies taking into account possible confounding parameters (and interactions) are needed to measure the impact of malaria control in an HIV endemic environment. In particular, the question should be answered if malaria control has an impact on the disease progression of HIV. The possible impact of these interventions on morbidity and mortality taking into account these parameters might have a major public health impact. This might be on the use of antiretroviral drugs, the incidence of clinical (eventually severe) malaria and spread of antimalarial resistance through immune compromised HIV patients (with and without antimalarial treatment).

Studies of alternative strategies that contribute (next to antiretrovirals) to the control and prevention of HIV pandemic are equally important and urgently needed. The need to design these strategies is critical given the high incidence of malaria and HIV in countries in Sub Saharan Africa such as Zambia and its serious impact on survival and the socio-economic situation. Moreover, a cost-benefit analysis might show that some alternative strategies have a major impact on the field with less technical, financial and social constraints than the strategies recommended so far.

All HIVP patients will be treated for opportunistic infections (OI) and receive antiretroviral drugs following the National guidelines on Management and Care of Patients with HIV/AIDS (also if this occurs after the study period). At the time they need cotrimoxazole prevention or/and receive antiretrovirals they would have reached a study endpoint and will be excluded from the trial though the follow up will continue.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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