Schistosomiasis intervention study

• Register: ISRCTN
• Last refreshed on: 24 February 2020
• Main ID: ISRCTN15371662
• Date of registration: 01/02/2017
• Prospective Registration: No
• Primary sponsor: Medical Research Council
• Public title: Schistosomiasis intervention study
• Scientific title: Effects of high-intensity versus low-intensity praziquantel treatment on HIV disease progression and immunological responses among HIV and Schistosoma mansoni co-infected patients
• Date of first enrolment: 01/07/2013
• Target sample size: 360
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN15371662
• Study type: Interventional
• Study design: Randomised controlled open trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Uganda

Contacts

• Name: Anatoli Kamali

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

HIV, schistosomiasis
Infections and Infestations

Intervention(s)

The HIV+/schistosome+ participants were randomized to high intensity versus low intensity praziquantel treatment in the ratio of 1:1.
1. The high intensity treatment group received initial treatment with two doses of praziquantel (40 mg/kg) one week apart, followed by praziquantel every three months.
2. The low intensity treatment group received a single dose of praziquantel (40 mg/kg) once a year, the first treatment being delayed to three months from the start of the follow up, in order to determine the effects of treatment by comparison with a short-term untreated group.

A comparison group with HIV but no S. mansoni infection was also included. Initially the comparison group received no anthelminthic treatment but later an amendment was introduced such that they received annual praziquantel as this is routine in fishing communities where low intensity infection might be undetected.

The duration of treatment and follow up was 15 months.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

SIS Protocol

Source(s) of Monetary Support

Seventh Framework Programme

Ethics review

Status:
Approval date:
Contact:

1. Research and Ethics Committee of the Uganda Virus Research Institute, 03/02/2012, ref: GC/127/12/02/01 2. Uganda National Council for Science and Technology (UNCST), 15/04/2012, ref: HS 1141

Results

• Results available: Yes
• Date Completed: 31/12/2015