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

NCT00373048 | Completed

• 1 other identifier: Mefloquine HIV zambia
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV-1 malaria Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Rate of decline of CD4 counts between different time points

  months 0, 6, 12 and 18

• Proportion of patients entering the AIDS stage (WHO stage 3,4)

  during 18 months

Secondary Outcomes (7)

• Mean difference in log plasma viral load at different time points,

  during 18 months

• Rate of decline of humoral immunity between different time points.

  during 18 months

• Proportion of patients with parasitaemia at the end of the intervention.

  during 18 months

• All cause disease incidence and prevalence (including malaria, TB)

  during 18 months

• Proportion of patients with Adverse event during monitoring

  during 18 months

Study Arms (2)

Placebo, tablet

PLACEBO COMPARATOR

Drug: placebo

mefloquine, tablet

EXPERIMENTAL

Drug: mefloquine

Interventions

mefloquine DRUG

tablet, once weekly

mefloquine, tablet

placebo DRUG

tablet, once weekly

Placebo, tablet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead

Study Sites (1)

Tropical Disease Research Center

Ndola, Cupperbelt, Zambia

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Mefloquine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Umberto D'Alessandro, MD,MSc, PHD

  Institute of Tropical Medicine Antwerp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 7, 2006
• Study Start: October 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: May 1, 2011
• Last Updated: May 24, 2011

Record last verified: 2011-05

Locations

ZA (1)