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A Study of Co-infections of HIV-1 and Schistosoma Mansoni and Its Impact on Praziquantel Treatment Outcomes

Primary Purpose

Anemia, Intestinal Helminthiasis, Intestinal Schistosomiasis

Status
Unknown status
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Praziquantel and Albendazole
Praziquantel and Albendazole
Praziquantel and Albendazole
Sponsored by
Catholic University of Health and Allied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anemia focused on measuring Human Immunodeficiency Virus-1, Schistosoma mansoni, Anemia, Immune response, Opportunistic infections, Tanzania

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Ilemela District
  • National Institute for Medical Research, Mwanza

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

HIV-1 co-infected with schistosoma mansoni

HIV-1 positive individuals with negative S. mansoni

Schistosoma mansoni positive but HIV-1 negative

HIV-1 and Schistosoma mansoni negative

Arm Description

HIV-1 patients co-infected with Schistosoma mansoni

HIV-1 positive individuals with negative Schistosoma mansoni

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

Individuals with no HIV-1 and S. mansoni infections

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Efficacy of praziquantel
Cure rates Reductions of infections intensities

Full Information

First Posted
February 20, 2012
Last Updated
March 2, 2012
Sponsor
Catholic University of Health and Allied Sciences
Collaborators
National Institute for Medical Research, Tanzania, University of Cambridge
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1. Study Identification

Unique Protocol Identification Number
NCT01541631
Brief Title
A Study of Co-infections of HIV-1 and Schistosoma Mansoni and Its Impact on Praziquantel Treatment Outcomes
Official 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 Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of Health and Allied Sciences
Collaborators
National Institute for Medical Research, Tanzania, University of Cambridge

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
The proposed study has the main objective to investigate the epidemiology of HIV-1 and Schistosoma mansoni co-infections and assess their association and progress of HIV positive individuals co-infected with S. mansoni. The study will also assess the impact of praziquantel treatment on S. mansoni related morbidities in co-infected HIV positive individuals with S. mansoni in Fishing villages, northwest Tanzania. The study is designed as a community based intervention trial, which consist of cross-sectional survey at the initial baseline survey followed by intervention trials. The initial baseline survey will include 2000 participants from the two villages. The objective of the survey is to determine the prevalence of HIV-1 infection and haemoglobin levels. Also, the socio-economic, demographic characteristics, individual behaviour in relation to HIV-1 and helminth transmission are recorded. In addition, the location and altitude of each household will determined using a hand-held Garmin GPSmap 60CSX, which has an accuracy of ± 5m. After initial survey, study participant will be grouped into 2 groups, one HIV-1 infected group and HIV-1 uninfected group. Blood sample for examination of CD4+, CD4+/CD8+ and HIV-1 viral loads will be obtained from HIV-1 positive participants every month for a period of six month. After 6 month of prospective longitudinal survey, the first follow-up survey of the recruited study participants will be conducted with the objective of determining prevalence and intensity of human intestinal schistosomiasis and other helminth infections. Other infections will also be examined, includes malaria and viral hepatitis. Furthermore, S. mansoni induced morbidity will be examined using ultrasonography. A blood sample will also be obtained for all HIV-1 positive patients, from which CD4+, CD4+/CD8+ and HIV-1 viral loads will be examined. In the same survey, individuals who tested HIV-1 negative at baseline will also be screened for HIV. After the first follow-up survey, three groups will be formed, Group A- individuals co-infected with HIV-1 and S. mansoni (N=270); Group B- individuals infected with HIV-1 but S. mansoni negative (N=180) and Group C- HIV-1 negative but S. mansoni positive (N=1320) (Figure 2). All individuals who will be infected with S. mansoni and other helminth detected in the study irrespective of HIV-1 serostatus will be treated with praziquantel (40mg/kg) and albendazole (400mg). At six to eight weeks after mass treatment, a second survey will be conducted in the recruited participants aiming at determining cure rates of S. mansoni after chemotherapy with praziquantel. The third survey will be conducted 12 month after the first follow-up survey with the aim of determining the change in CD4+, CD4+/CD8+, HIV-1 viral loads, HIV-1 progression and reversibility of the S. mansoni related liver morbidity after praziquantel

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Intestinal Helminthiasis, Intestinal Schistosomiasis, Human Immunodeficiency Virus I Infection, Hematologic Diseases, Opportunistic Infections
Keywords
Human Immunodeficiency Virus-1, Schistosoma mansoni, Anemia, Immune response, Opportunistic infections, Tanzania

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIV-1 co-infected with schistosoma mansoni
Arm Type
Experimental
Arm Description
HIV-1 patients co-infected with Schistosoma mansoni
Arm Title
HIV-1 positive individuals with negative S. mansoni
Arm Type
No Intervention
Arm Description
HIV-1 positive individuals with negative Schistosoma mansoni
Arm Title
Schistosoma mansoni positive but HIV-1 negative
Arm Type
Experimental
Arm Description
Schistosoma mansoni positive individuals but HIV-1 negative to be compared with HIV-1 co-infected with Schistosoma mansoni individuals
Arm Title
HIV-1 and Schistosoma mansoni negative
Arm Type
No Intervention
Arm Description
Individuals with no HIV-1 and S. mansoni infections
Intervention Type
Drug
Intervention Name(s)
Praziquantel and Albendazole
Other Intervention Name(s)
DISTOCIDE, ZENTEL
Intervention Description
Praziquantel Tablet - 40mg/kgBWT given once Albendazole Tablet - 400mg once
Intervention Type
Drug
Intervention Name(s)
Praziquantel and Albendazole
Other Intervention Name(s)
DISTOCIDE, ZENTEL
Intervention Description
Praziquantel- 40mg/kgBWT Albendazole - 400mg once
Intervention Type
Drug
Intervention Name(s)
Praziquantel and Albendazole
Other Intervention Name(s)
DISTOCIDE, ZENTEL
Intervention Description
Praziquantel- 40MG/KG ONCE Albendazole - 400mg once
Primary Outcome Measure Information:
Title
The impact of Praziquantel in HIV-1 individuals co-infected with Schistosoma mansoni
Description
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.
Time Frame
12 month follow-up
Secondary Outcome Measure Information:
Title
Efficacy of praziquantel
Description
Cure rates Reductions of infections intensities
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Humphrey D Mazigo
Organizational Affiliation
Makerere University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ilemela District
City
Mwanza
State/Province
Lake Victoria Zone
ZIP/Postal Code
+255
Country
Tanzania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Humphrey D Mazigo
Facility Name
National Institute for Medical Research, Mwanza
City
Mwanza
State/Province
Lake Victoria Zone
ZIP/Postal Code
+255
Country
Tanzania

12. IPD Sharing Statement

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A Study of Co-infections of HIV-1 and Schistosoma Mansoni and Its Impact on Praziquantel Treatment Outcomes

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