- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01541631
A Study of Co-infections of HIV-1 and Schistosoma Mansoni and Its Impact on Praziquantel Treatment Outcomes
March 2, 2012 updated by: Humphrey Mazigo, Msc, MPH, Catholic University of Health and Allied Sciences
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.
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
2000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lake Victoria Zone
-
Mwanza, Lake Victoria Zone, Tanzania, +255
- Ilemela District
-
Principal Investigator:
- Humphrey D Mazigo
-
Mwanza, Lake Victoria Zone, Tanzania, +255
- National Institute for Medical Research, Mwanza
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 53 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HIV-1 co-infected with schistosoma mansoni
HIV-1 patients co-infected with Schistosoma mansoni
|
Praziquantel Tablet - 40mg/kgBWT given once Albendazole Tablet - 400mg once
Other Names:
Praziquantel- 40mg/kgBWT Albendazole - 400mg once
Other Names:
Praziquantel- 40MG/KG ONCE Albendazole - 400mg once
Other Names:
|
No Intervention: HIV-1 positive individuals with negative S. mansoni
HIV-1 positive individuals with negative Schistosoma mansoni
|
Praziquantel Tablet - 40mg/kgBWT given once Albendazole Tablet - 400mg once
Other Names:
Praziquantel- 40mg/kgBWT Albendazole - 400mg once
Other Names:
Praziquantel- 40MG/KG ONCE Albendazole - 400mg once
Other Names:
|
Experimental: Schistosoma mansoni positive but HIV-1 negative
Schistosoma mansoni positive individuals but HIV-1 negative to be compared with HIV-1 co-infected with Schistosoma mansoni individuals
|
Praziquantel Tablet - 40mg/kgBWT given once Albendazole Tablet - 400mg once
Other Names:
Praziquantel- 40mg/kgBWT Albendazole - 400mg once
Other Names:
Praziquantel- 40MG/KG ONCE Albendazole - 400mg once
Other Names:
|
No Intervention: HIV-1 and Schistosoma mansoni negative
Individuals with no HIV-1 and S. mansoni infections
|
Praziquantel Tablet - 40mg/kgBWT given once Albendazole Tablet - 400mg once
Other Names:
Praziquantel- 40mg/kgBWT Albendazole - 400mg once
Other Names:
Praziquantel- 40MG/KG ONCE Albendazole - 400mg once
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The impact of Praziquantel in HIV-1 individuals co-infected with Schistosoma mansoni
Time Frame: 12 month follow-up
|
|
12 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of praziquantel
Time Frame: 12 months
|
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Humphrey D Mazigo, Makerere University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Anticipated)
June 1, 2013
Study Completion (Anticipated)
June 1, 2013
Study Registration Dates
First Submitted
February 20, 2012
First Submitted That Met QC Criteria
February 29, 2012
First Posted (Estimate)
March 1, 2012
Study Record Updates
Last Update Posted (Estimate)
March 5, 2012
Last Update Submitted That Met QC Criteria
March 2, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Disease Attributes
- Vector Borne Diseases
- Parasitic Diseases
- Slow Virus Diseases
- Trematode Infections
- HIV Infections
- Infections
- Communicable Diseases
- Hematologic Diseases
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Helminthiasis
- Coinfection
- Opportunistic Infections
- Schistosomiasis
- Schistosomiasis mansoni
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiprotozoal Agents
- Antiparasitic Agents
- Anthelmintics
- Antiplatyhelmintic Agents
- Anticestodal Agents
- Albendazole
- Praziquantel
Other Study ID Numbers
- 087540
- 00005856/2011 (Other Identifier: Makerere University College of Health Sciences)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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