NCT01541631

Brief Summary

In this study, it is hypothesized that helminth infections modulate immune responses against HIV-1 infection resulting into increased HIV-1 multiplication, faster progression to AIDS and increased episodes of AIDS-related opportunistic infections. Furthermore, the effect of helminth infections on progression of HIV-1 infection is dependent on helminth infection intensity, host background immunity, nutritional status, demographic factors and socio-economic status. Also, treatment of helminth infections using praziquantel and albendazole among HIV-1 infected individuals will lead to reduction in HIV-1 viral loads, improvement of CD4+ counts, CD4+/CD8+ ratio and Hb levels, improved weight gain and reduction of episodes of HIV-1 related opportunistic infections. In addition, HIV-1 infection is associated with poor anthelminthic treatment outcome as compared to non-HIV infected individuals

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 1, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 5, 2012

Status Verified

March 1, 2012

Enrollment Period

1.1 years

First QC Date

February 20, 2012

Last Update Submit

March 2, 2012

Conditions

AnemiaIntestinal HelminthiasisIntestinal SchistosomiasisHuman Immunodeficiency Virus I InfectionHematologic DiseasesOpportunistic Infections

Keywords

Human Immunodeficiency Virus-1Schistosoma mansoniAnemiaImmune responseOpportunistic infectionsTanzania

Outcome Measures

Primary Outcomes (1)

  • The impact of Praziquantel in HIV-1 individuals co-infected with Schistosoma mansoni

    * Impact of praziquantel treatment on CD4+,CD4+/CD8+, HIV-1 viral loads haemoglobin level, reversibility of liver pathology and occurance of opportunistic infection * Prevalence of co-infections of HIV-1 and Schistosoma mansoni * Prospective longitudinal association between HIV-1 and S. mansoni, and the progression of HIV to AIDS, according to S. mansoni infection status.

    12 month follow-up

Secondary Outcomes (1)

  • Efficacy of praziquantel

    12 months

Study Arms (4)

HIV-1 co-infected with schistosoma mansoni

EXPERIMENTAL

HIV-1 patients co-infected with Schistosoma mansoni

Drug: Praziquantel and Albendazole

HIV-1 positive individuals with negative S. mansoni

NO INTERVENTION

HIV-1 positive individuals with negative Schistosoma mansoni

Drug: Praziquantel and Albendazole

Schistosoma mansoni positive but HIV-1 negative

EXPERIMENTAL

Schistosoma mansoni positive individuals but HIV-1 negative to be compared with HIV-1 co-infected with Schistosoma mansoni individuals

Drug: Praziquantel and Albendazole

HIV-1 and Schistosoma mansoni negative

NO INTERVENTION

Individuals with no HIV-1 and S. mansoni infections

Drug: Praziquantel and Albendazole

Interventions

Praziquantel and AlbendazoleDRUG

Praziquantel Tablet - 40mg/kgBWT given once Albendazole Tablet - 400mg once

Also known as: DISTOCIDE, ZENTEL
HIV-1 co-infected with schistosoma mansoni

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Permanent residents and those who have lived in the village for more than 2 years.
  • HIV-1 positive individuals only those with CD4+ ≥ 400 cells/μl

You may not qualify if:

  • HIV-1 positive individuals with CD4+ \< 350 cells/μl,
  • Those who are on antiretroviral therapy (ARV)
  • Pregnant women are excluded.
  • Participants with chronic diseases such as leukemia, tuberculosis and viral hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ilemela District

Mwanza, Lake Victoria Zone, +255, Tanzania

Location

National Institute for Medical Research, Mwanza

Mwanza, Lake Victoria Zone, +255, Tanzania

Location

MeSH Terms

Conditions

AnemiaIntestinal helminthiasisSchistosomiasis mansoniHematologic DiseasesOpportunistic InfectionsSchistosomiasis

Interventions

PraziquantelAlbendazole

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesTrematode InfectionsHelminthiasisParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazoles

Study Officials

  • Humphrey D Mazigo

    Makerere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Epidemiology of Human Immunodeficiency Virus (HIV-1) and Schistosoma mansoni co-infections and its impact on anthelminthic treatment outcome among HIV-1 infected individuals in fishing communities in Mwanza region, Northwestern Tanzania.

Study Record Dates

First Submitted

February 20, 2012

First Posted

March 1, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

March 5, 2012

Record last verified: 2012-03

Locations

TA(2)