NCT00499876

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

July 11, 2007

Last Update Submit

January 25, 2017

Conditions

HIV InfectionsMalaria

Keywords

Human immune deficiency virusAcquired immune deficiency syndromemalariamefloquineprophylaxisHIV/AIDSTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • Measure the effects of antimalarials on CD4 cell count decline and HIV viral load increase in study patients

    12 months

Secondary Outcomes (1)

  • Measure the effect of malaria prophylaxis on malaria parasitaemia and haemoglobin levels in study patients

    12 months

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: mefloquine

B

PLACEBO COMPARATOR
Other: placebo

Interventions

mefloquineDRUG

250mg weekly PO for 6 months

A
placeboOTHER

1 tablet weekly PO for 6 months

B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Komfo Anokye Teaching Hospital

Kumasi, Kumasi, 1934, Ghana

Location

MeSH Terms

Conditions

HIV InfectionsMalariaAcquired Immunodeficiency Syndrome

Interventions

Mefloquine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesProtozoan InfectionsParasitic DiseasesMosquito-Borne DiseasesVector Borne DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

QuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ruby Martin-Peprah, MBChB, PhD

    Komfo Anokye Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 12, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2008

Study Completion

December 1, 2009

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

GH(1)