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

HIV Infections Clinical Trial

Official title:

Mefloquine Malaria Prophylaxis in HIV-1 Infected Individuals and Its Influence on the Evolution Towards AIDS: a Randomized Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373048
• Other study ID #: Mefloquine HIV zambia
• Status: Completed
• Phase: N/A
• First received: September 5, 2006
• Last updated: May 23, 2011
• Start date: October 2005
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Health authority: Zambia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2011
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• mefloquine
tablet, once weekly
• placebo
tablet, once weekly

Locations

Country	Name	City	State
Zambia	Tropical Disease Research Center	Ndola	Cupperbelt

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of decline of CD4 counts between different time points		months 0, 6, 12 and 18	No
Primary	Proportion of patients entering the AIDS stage (WHO stage 3,4)		during 18 months	No
Secondary	Mean difference in log plasma viral load at different time points,		during 18 months	No
Secondary	Rate of decline of humoral immunity between different time points.		during 18 months	No
Secondary	Proportion of patients with parasitaemia at the end of the intervention.		during 18 months	No
Secondary	All cause disease incidence and prevalence (including malaria, TB)		during 18 months	No
Secondary	Proportion of patients with Adverse event during monitoring		during 18 months	Yes
Secondary	Prevalence of anaemia at different time points		during 18 months	No
Secondary	Incidence of severe anaemia		during 18 months	Yes