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

This study has been completed.
Sponsor:
Information provided by:
Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier:
NCT00373048
First received: September 5, 2006
Last updated: May 23, 2011
Last verified: May 2011

September 5, 2006
May 23, 2011
October 2005
December 2007   (final data collection date for primary outcome measure)
  • Rate of decline of CD4 counts between different time points [ Time Frame: months 0, 6, 12 and 18 ] [ Designated as safety issue: No ]
  • Proportion of patients entering the AIDS stage (WHO stage 3,4) [ Time Frame: during 18 months ] [ Designated as safety issue: No ]
  • Rate of decline of CD4 counts between different time points
  • Proportion of patients entering the AIDS stage (WHO stage 3,4)
Complete list of historical versions of study NCT00373048 on ClinicalTrials.gov Archive Site
  • Mean difference in log plasma viral load at different time points, [ Time Frame: during 18 months ] [ Designated as safety issue: No ]
  • Rate of decline of humoral immunity between different time points. [ Time Frame: during 18 months ] [ Designated as safety issue: No ]
  • Proportion of patients with parasitaemia at the end of the intervention. [ Time Frame: during 18 months ] [ Designated as safety issue: No ]
  • All cause disease incidence and prevalence (including malaria, TB) [ Time Frame: during 18 months ] [ Designated as safety issue: No ]
  • Proportion of patients with Adverse event during monitoring [ Time Frame: during 18 months ] [ Designated as safety issue: Yes ]
  • Prevalence of anaemia at different time points [ Time Frame: during 18 months ] [ Designated as safety issue: No ]
  • Incidence of severe anaemia [ Time Frame: during 18 months ] [ Designated as safety issue: Yes ]
  • Mean difference in log plasma viral load at different time points,
  • Rate of decline of humoral immunity between different time points.
  • Proportion of patients with parasitaemia at the end of the intervention.
  • All cause disease incidence and prevalence (including malaria, TB)
  • Proportion of patients with Adverse event during monitoring
  • Prevalence of anaemia at different time points
  • Incidence of severe anaemia
Not Provided
Not Provided
 
Mefloquine Prophylaxis in HIV-1 Individuals: a Randomized Placebo-controlled Trial
Mefloquine Malaria Prophylaxis in HIV-1 Infected Individuals and Its Influence on the Evolution Towards AIDS: a Randomized Placebo-controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infections
  • Drug: mefloquine
    tablet, once weekly
    Other Name: mefloquine
  • Drug: placebo
    tablet, once weekly
    Other Name: placebo
  • Placebo Comparator: Placebo, tablet
    Intervention: Drug: placebo
  • Experimental: mefloquine, tablet
    Intervention: Drug: mefloquine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
May 2011
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Zambia
 
NCT00373048
Mefloquine HIV zambia
No
Professor Umberto D'Alessandro, Institute of Tropical Medicine
Institute of Tropical Medicine, Belgium
Not Provided
Study Director: Umberto D'Alessandro, MD,MSc, PHD Institute of Tropical Medicine, Antwerp
Institute of Tropical Medicine, Belgium
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP