The Effect of Malaria on Disease Progression of HIV/AIDS

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Gates Malaria Partnership.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Noguchi Memorial Institute for Medical Research, University of Ghana
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00499876
First received: July 11, 2007
Last updated: March 5, 2009
Last verified: March 2009
  Purpose

The purpose of this study is to find out whether malaria affects how HIV/AIDS disease progresses in an infected patient, and to determine the effect of reducing malaria infection on HIV disease progression in Kumasi


Condition Intervention
HIV Infections
Malaria
Drug: mefloquine
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Malaria on Disease Progression of HIV/AIDS in Kumasi, Ghana

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • Measure the effects of antimalarials on CD4 cell count decline and HIV viral load increase in study patients [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measure the effect of malaria prophylaxis on malaria parasitaemia and haemoglobin levels in study patients [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 197
Study Start Date: October 2007
Estimated Study Completion Date: March 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: mefloquine
250mg weekly PO for 6 months
Placebo Comparator: B Other: placebo
1 tablet weekly PO for 6 months

Detailed Description:

Malaria and HIV are among the most prevalent infectious diseases in sub-Saharan Africa and are major causes of morbidity and mortality in the sub region. Because of the wide-spread geographical overlap in HIV and malaria, the probability for co-infections and the potential for interactions between the two diseases are high. Even modest interactions may have substantial impact in populations.

It is now clear that there are interactions between the two infections. HIV associated immunosuppression erodes the malaria acquired immunity of the HIV patients. The risk of parasitaemia, high parasite density and malarial fever increases with decreasing CD4 T cell counts and increasing viral load of HIV patients. Plasmodium falciparum has been shown to stimulate HIV replication through the production of cytokines (including interleukin 6 and tumor necrosing factor α (TNF-α)) by activated lymphocytes. Malaria treatment in HIV patients with malaria resulted in significant reduction of the median HIV viral load concentration.

Although it is now clear that malaria causes transient rises in HIV-1 viral loads, could repeated episodes of malaria in areas of intense transmission lead to a cumulative effect on viral load and accelerate decline in CD4 counts thereby accelerating HIV disease progression? If so, could the decline in CD4 count in individuals who have not yet started on anti-retroviral drugs be slowed down by intermittent malaria treatment?

A controlled interventional study with mefloquine as malaria prophylaxis for 6 months will be used in HIV/AIDS patients who are not already on ARTs in KATH, and malaria parasitaemia and density, HIV viral load and CD4 cell count will be monitored in both arms.

Comparison: Malaria parasitaemia and density, HIV viral loads and CD4 cell counts will be compared between the intervention group and the control groups to determine the effect o malaria and malaria prophylaxis on HIV disease progression

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult HIV patients attending the Komfo Anokye Teaching Hospital (KATH) HIV clinic who do not yet fulfil the criteria for ARTs. This includes a CD 4 cell count of ≥ 300x106/l and World Health Organisation HIV stage I-III

Exclusion Criteria:

  • All children with HIV infection attending the HIV clinic at KATH
  • Adult HIV patients on ARTs attending the HIV clinic at KATH
  • Adult HIV patients with WHO stage IV and V AIDS
  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: NCT00499876

Locations
Ghana
Komfo Anokye Teaching Hospital
Kumasi, Ghana, 1934
Sponsors and Collaborators
Gates Malaria Partnership
Noguchi Memorial Institute for Medical Research, University of Ghana
Investigators
Principal Investigator: Ruby Martin-Peprah, MBChB, PhD Komfo Anokye Teaching Hospital
  More Information

No publications provided

Responsible Party: Dr Ruby Martin-Peprah, Komfo Anokye teaching Hospital
ClinicalTrials.gov Identifier: NCT00499876     History of Changes
Other Study ID Numbers: REG_9, KATH_GMP_1
Study First Received: July 11, 2007
Last Updated: March 5, 2009
Health Authority: Ghana: Ministry of Health

Keywords provided by Gates Malaria Partnership:
Human immune deficiency virus
Acquired immune deficiency syndrome
malaria
mefloquine
prophylaxis
HIV/AIDS
Treatment Naive

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

ClinicalTrials.gov processed this record on September 11, 2014