Schistosomiasis intervention study

Not Applicable

Completed

• Conditions: HIV, schistosomiasis; Infections and Infestations

• Registration Number: ISRCTN15371662
• Lead Sponsor: Medical Research Council

Brief Summary

2019 results in https://pubmed.ncbi.nlm.nih.gov/30498791 (added 30/01/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-12-31
• Study Start: 2017-02-01
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 363

Inclusion Criteria

1. ART-naïve HIV-positive men and women with evidence of co-infection with S. mansoni
2. Aged 18 years or over
3. Not eligible for ART (CD4 count more than 350 cells/mm3 or not in WHO Stage IV and advanced stage III)
4. Willing to provide a stool sample for testing S. mansoni and other worms and accept treatment with praziquantel and albendazole
5. Willing to provide blood for viral loads, CD4 count and other blood tests
6. Able and willing to provide informed consent (literacy is not required)
7. Willing to undergo HIV testing, counseling and receive HIV test results
8. Available for follow-up for study duration
9. Able and willing to provide adequate locator information for tracking purposes, and willing to be contacted by the study staff

Exclusion Criteria

1. Pregnancy or planning to be pregnant during study period
2. Has taken praziquantel in the preceding 3 months
3. Symptomatic helminth infection (haemoglobin less than 8 g/dl, bloody diarrhea, clinically apparent liver disease)
4. Symptomatic complications of S.mansoni (vomiting blood, hepatosplenomegaly)
5. S. mansoni egg count more than 2000/g of stool as evidence points a high egg burden (>2000 eggs/g) highly associated with periportal fibrosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
log10 plasma HIV-1 RNA levels, measured using the Ampliprep/Taqman V2.0 HIV-1 viral load assay at 12 and 60 weeks

Secondary Outcome Measures

Name	Time	Method
<br> 1. Prevalence of S. mansoni, measured by parasitological examination of stool at 12 and 60 weeks<br> 2. CD4 count, measured using Multiset™ software on a FACSCalibur at 12 and 60 weeks<br> 3. Clinical course of HIV disease, measured by documenting clinical events such as opportunistic infections and WHO staging at all visits<br> 4. All-cause mortality, measured at all follow-up visits<br>