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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Catholic University of Health and Allied Sciences.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
National Institute for Medical Research, Tanzania
University of Cambridge
Information provided by (Responsible Party):
Humphrey Mazigo, Msc, MPH, Makerere University
ClinicalTrials.gov Identifier:
NCT01541631
First received: February 20, 2012
Last updated: March 2, 2012
Last verified: March 2012

February 20, 2012
March 2, 2012
May 2012
June 2013   (final data collection date for primary outcome measure)
The impact of Praziquantel in HIV-1 individuals co-infected with Schistosoma mansoni [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
  • 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.
Same as current
Complete list of historical versions of study NCT01541631 on ClinicalTrials.gov Archive Site
Efficacy of praziquantel [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cure rates
  • Reductions of infections intensities
Same as current
Not Provided
Not Provided
 
A Study of Co-infections of HIV-1 and Schistosoma Mansoni and Its Impact on Praziquantel Treatment Outcomes
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

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

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Anemia
  • Intestinal Helminthiasis
  • Intestinal Schistosomiasis
  • Human Immunodeficiency Virus I Infection
  • Hematologic Diseases
  • Opportunistic Infections
  • Drug: Praziquantel and Albendazole
    Praziquantel Tablet - 40mg/kgBWT given once Albendazole Tablet - 400mg once
    Other Names:
    • DISTOCIDE
    • ZENTEL
  • Drug: Praziquantel and Albendazole
    Praziquantel- 40mg/kgBWT Albendazole - 400mg once
    Other Names:
    • DISTOCIDE
    • ZENTEL
  • Drug: Praziquantel and Albendazole
    Praziquantel- 40MG/KG ONCE Albendazole - 400mg once
    Other Names:
    • DISTOCIDE
    • ZENTEL
  • Experimental: HIV-1 co-infected with schistosoma mansoni
    HIV-1 patients co-infected with Schistosoma mansoni
    Interventions:
    • Drug: Praziquantel and Albendazole
    • Drug: Praziquantel and Albendazole
    • Drug: Praziquantel and Albendazole
  • No Intervention: HIV-1 positive individuals with negative S. mansoni
    HIV-1 positive individuals with negative Schistosoma mansoni
    Interventions:
    • Drug: Praziquantel and Albendazole
    • Drug: Praziquantel and Albendazole
  • 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
    Interventions:
    • Drug: Praziquantel and Albendazole
    • Drug: Praziquantel and Albendazole
  • No Intervention: HIV-1 and Schistosoma mansoni negative
    Individuals with no HIV-1 and S. mansoni infections
    Intervention: Drug: Praziquantel and Albendazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
2000
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
15 Years to 55 Years
Yes
Not Provided
Tanzania
 
NCT01541631
087540, 00005856/2011
No
Humphrey Mazigo, Msc, MPH, Makerere University
Catholic University of Health and Allied Sciences
  • National Institute for Medical Research, Tanzania
  • University of Cambridge
Principal Investigator: Humphrey D Mazigo Makerere University School of Public Health
Catholic University of Health and Allied Sciences
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP