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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00373048
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : May 24, 2011
Information provided by:
Institute of Tropical Medicine, Belgium

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 placebo control group and followed up for 18 months.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: mefloquine Drug: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mefloquine Malaria Prophylaxis in HIV-1 Infected Individuals and Its Influence on the Evolution Towards AIDS: a Randomized Placebo-controlled Trial
Study Start Date : October 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Malaria

Arm Intervention/treatment
Placebo Comparator: Placebo, tablet Drug: placebo
tablet, once weekly

Experimental: mefloquine, tablet Drug: mefloquine
tablet, once weekly

Primary Outcome Measures :
  1. Rate of decline of CD4 counts between different time points [ Time Frame: months 0, 6, 12 and 18 ]
  2. Proportion of patients entering the AIDS stage (WHO stage 3,4) [ Time Frame: during 18 months ]

Secondary Outcome Measures :
  1. Mean difference in log plasma viral load at different time points, [ Time Frame: during 18 months ]
  2. Rate of decline of humoral immunity between different time points. [ Time Frame: during 18 months ]
  3. Proportion of patients with parasitaemia at the end of the intervention. [ Time Frame: during 18 months ]
  4. All cause disease incidence and prevalence (including malaria, TB) [ Time Frame: during 18 months ]
  5. Proportion of patients with Adverse event during monitoring [ Time Frame: during 18 months ]
  6. Prevalence of anaemia at different time points [ Time Frame: during 18 months ]
  7. Incidence of severe anaemia [ Time Frame: during 18 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00373048

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Tropical Disease Research Center
Ndola, Cupperbelt, Zambia
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
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Study Director: Umberto D'Alessandro, MD,MSc, PHD Institute of Tropical Medicine, Antwerp

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Responsible Party: Professor Umberto D'Alessandro, Institute of Tropical Medicine Identifier: NCT00373048    
Other Study ID Numbers: Mefloquine HIV zambia
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: May 24, 2011
Last Verified: May 2011
Keywords provided by Institute of Tropical Medicine, Belgium:
HIV-1 malaria Clinical Trial
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents