Mefloquine Prophylaxis in HIV-1 Individuals: a Randomized Placebo-controlled Trial
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

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 placebo control group and followed up for 18 months.
    

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 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.

      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.

      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.
    

Intervention name(s): mefloquine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): tablet, once weekly; tablet, once weekly
Intervention MeSH terms: Mefloquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV-1 malaria Clinical Trial