Trial record 12 of 31 for:    " February 15, 2012":" March 16, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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


Condition Intervention
Anemia
Intestinal Helminthiasis
Intestinal Schistosomiasis
Human Immunodeficiency Virus I Infection
Hematologic Diseases
Opportunistic Infections
Drug: Praziquantel and Albendazole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Catholic University of Health and Allied Sciences:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Efficacy of praziquantel [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • Cure rates
    • Reductions of infections intensities


Estimated Enrollment: 2000
Study Start Date: May 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIV-1 co-infected with schistosoma mansoni
HIV-1 patients co-infected with Schistosoma mansoni
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
No Intervention: HIV-1 positive individuals with negative S. mansoni
HIV-1 positive individuals with negative Schistosoma mansoni
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: 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
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
No Intervention: HIV-1 and Schistosoma mansoni negative
Individuals with no HIV-1 and S. mansoni infections
Drug: Praziquantel and Albendazole
Praziquantel- 40mg/kgBWT Albendazole - 400mg once
Other Names:
  • DISTOCIDE
  • ZENTEL

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

  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541631

Locations
Tanzania
Ilemela District Not yet recruiting
Mwanza, Lake Victoria Zone, Tanzania, +255
Principal Investigator: Humphrey D Mazigo         
National Institute for Medical Research, Mwanza Not yet recruiting
Mwanza, Lake Victoria Zone, Tanzania, +255
Sponsors and Collaborators
Catholic University of Health and Allied Sciences
National Institute for Medical Research, Tanzania
University of Cambridge
Investigators
Principal Investigator: Humphrey D Mazigo Makerere University School of Public Health
  More Information

No publications provided

Responsible Party: Humphrey Mazigo, Msc, MPH, 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., Makerere University
ClinicalTrials.gov Identifier: NCT01541631     History of Changes
Other Study ID Numbers: 087540, 00005856/2011
Study First Received: February 20, 2012
Last Updated: March 2, 2012
Health Authority: Tanzania: National Institute for Medical Research

Keywords provided by Catholic University of Health and Allied Sciences:
Human Immunodeficiency Virus-1
Schistosoma mansoni
Anemia
Immune response
Opportunistic infections
Tanzania

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Anemia
Helminthiasis
Hematologic Diseases
Immunologic Deficiency Syndromes
Opportunistic Infections
Schistosomiasis
Schistosomiasis mansoni
Coinfection
Intestinal Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Parasitic Diseases
Infection
Trematode Infections
Gastrointestinal Diseases
Digestive System Diseases
Albendazole
Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014