Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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 Intervention
HIV Infections
Drug: mefloquine
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Institute of Tropical Medicine, Belgium:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: October 2005
Study Completion Date: May 2011
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo, tablet Drug: placebo
tablet, once weekly
Other Name: placebo
Experimental: mefloquine, tablet Drug: mefloquine
tablet, once weekly
Other Name: mefloquine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373048

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

No publications provided

Responsible Party: Professor Umberto D'Alessandro, Institute of Tropical Medicine
ClinicalTrials.gov Identifier: NCT00373048     History of Changes
Other Study ID Numbers: Mefloquine HIV zambia
Study First Received: September 5, 2006
Last Updated: May 23, 2011
Health Authority: Zambia: Ministry of Health

Keywords provided by Institute of Tropical Medicine, Belgium:
HIV-1 malaria Clinical Trial

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Mefloquine
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014