AnemiaNCT01541631
A Study of Co-infections of HIV-1 and Schistosoma Mansoni and Its Impact on Praziquantel Treatment Outcomes
A study testing Praziquantel and Albendazole in people with Anemia and Intestinal Helminthiasis, run by Catholic University of Health and Allied Sciences at 2 sites in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Intestinal Helminthiasis, Intestinal Schistosomiasis
- What is being tested?
- Praziquantel and Albendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 2 sitesTanzania
- Study dates
- May 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Tanzania2 sites
Ilemela District
Mwanza, Lake Victoria Zone, +255
Humphrey D Mazigo
National Institute for Medical Research, Mwanza
Mwanza, Lake Victoria Zone, +255
About this study
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.
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
Read the 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
- Conditions
- Anemia, Intestinal Helminthiasis, Intestinal Schistosomiasis, Human Immunodeficiency Virus I Infection, Hematologic Diseases, Opportunistic Infections
- Being tested
- Praziquantel and Albendazole
- Keywords
- Human Immunodeficiency Virus-1, Schistosoma mansoni, Anemia, Immune response, Opportunistic infections, Tanzania
- Medical subject headings
- Anemia, Intestinal helminthiasis, Schistosomiasis mansoni, Hematologic Diseases, Opportunistic Infections, Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Praziquantel and AlbendazoleDrug
Also called DISTOCIDE, ZENTEL
Praziquantel Tablet - 40mg/kgBWT given once Albendazole Tablet - 400mg once
Praziquantel and AlbendazoleDrug
Also called DISTOCIDE, ZENTEL
Praziquantel- 40mg/kgBWT Albendazole - 400mg once
Praziquantel and AlbendazoleDrug
Also called DISTOCIDE, ZENTEL
Praziquantel- 40MG/KG ONCE Albendazole - 400mg once
| Study group | Role | What they receive |
|---|---|---|
| HIV-1 co-infected with schistosoma mansoni | Experimental | HIV-1 patients co-infected with Schistosoma mansoni Receives: Drug: Praziquantel and Albendazole |
| HIV-1 positive individuals with negative S. mansoni | No intervention | HIV-1 positive individuals with negative Schistosoma mansoni Receives: 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 Receives: Drug: Praziquantel and Albendazole |
| HIV-1 and Schistosoma mansoni negative | No intervention | Individuals with no HIV-1 and S. mansoni infections Receives: Drug: Praziquantel and Albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 month follow-up
Secondary outcomes (1)
Efficacy of praziquantel
- Cure rates
- Reductions of infections intensities
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of Health and Allied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, University of Cambridge
- Responsible party
- Principal investigator, Humphrey Mazigo, Msc, MPH, Makerere University
- Investigators
- Humphrey D Mazigo, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541631
- Sponsor's protocol ID
- 087540
- Other IDs
- 00005856/2011
- Status last verified
- Mar 2012
- First submitted
- 20 Feb 2012
- Last updated
- 5 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01541631
- Acronym / sponsor ID
- 087540
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Catholic University of Health and Allied SciencesUniversity, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, University of Cambridge
- Study start
- May 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 1 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV-1 co-infected with schistosoma mansoni | Experimental | Drug: Praziquantel and AlbendazoleHIV-1 patients co-infected with Schistosoma mansoni |
| HIV-1 positive individuals with negative S. mansoni | No intervention | Drug: Praziquantel and AlbendazoleHIV-1 positive individuals with negative Schistosoma mansoni |
| Schistosoma mansoni positive but HIV-1 negative | Experimental | Drug: Praziquantel and AlbendazoleSchistosoma mansoni positive individuals but HIV-1 negative to be compared with HIV-1 co-infected with Schistosoma mansoni individuals |
| HIV-1 and Schistosoma mansoni negative | No intervention | Drug: Praziquantel and AlbendazoleIndividuals with no HIV-1 and S. mansoni infections |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Praziquantel and AlbendazoleAlso: DISTOCIDE, ZENTELPraziquantel Tablet - 40mg/kgBWT given once Albendazole Tablet - 400mg once | Drug | HIV-1 co-infected with schistosoma mansoni |
| Praziquantel and AlbendazoleAlso: DISTOCIDE, ZENTELPraziquantel- 40mg/kgBWT Albendazole - 400mg once | Drug | HIV-1 and Schistosoma mansoni negative, HIV-1 co-infected with schistosoma mansoni, HIV-1 positive individuals with negative S. mansoni, Schistosoma mansoni positive but HIV-1 negative |
| Praziquantel and AlbendazoleAlso: DISTOCIDE, ZENTELPraziquantel- 40MG/KG ONCE Albendazole - 400mg once | Drug | HIV-1 co-infected with schistosoma mansoni, HIV-1 positive individuals with negative S. mansoni, Schistosoma mansoni positive but HIV-1 negative |
Primary outcome
The impact of Praziquantel in HIV-1 individuals co-infected with Schistosoma mansoni
Time frame: 12 month follow-up
* 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.
1 secondary outcome
Efficacy of praziquantel
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Humphrey D Mazigo principal investigator
Makerere University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Praziquantel and Albendazole in people with Anemia and Intestinal Helminthiasis, run by Catholic University of Health and Allied Sciences at 2 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of Praziquantel in HIV-1 individuals co-infected with Schistosoma mansoni (time frame: 12 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2012.