Understanding Excretion and Infectivity… | Clinical Trial

Key information

Conditions

Zika Virus Arbovirus Infections Flaviviridae Infections Flavivirus Infections Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases Zika Virus Infection

Sex eligibility

Male

Study type

Observational

Primary location

Trinidad and Tobago IVF & Fertility Centre

Maraval, Trinidad and Tobago

About this study

In this prospective observational study the investigators will report on 20 male subjects with proven WHO-classification Zika infection. These subjects will be followed up for a maximum of 12 months to observe the presence, viral load and infectivity of Zika virus (ZIKV) in semen over time.

Knowledge of the possible presence, infectivity and persistence of ZIKV in semen will provide evidence-based data for

estimating of the risk of sexual transmission of ZIKV in the general population
antenatal guidelines for the prevention of sexual transmission of ZIKV to the fetus
advising couples on the length of time that pregnancy should be avoided in women wishing to conceive after their partner's ZIKV infection
strategies to prevent transmission of ZIKV infection through assisted reproductive treatment (ART)
advice on gamete cryopreservation
optimising investigations for diagnosis of ZIKV in males.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male aged 18-50 years
ZIKV symptoms within the preceding thirty days
Confirmed ZIKV infection (WHO criteria)
Able to ejaculate to produce a semen sample

Exclusion criteria

Current urological malignancy

Treatment and study plan

Semen analysis and semen PCR for Zika virus

Other

Every two weeks subjects provide a semen sample which is analysed and then frozen for RT-PCR and viral load. Semen sample testing for the presence of ZIKV (Institute of Tropical Medicine, Belgium) will be performed using both a ZIKV-specific, in-house duplex real-time RT-PCR, targeting a 102bp and 121bp sequence of the NS5 gene and the RealStar® Zika Virus RT-PCR Kit (Altona). Quantitative viral load RNA measurements will be expressed utilizing threshold cycle values because a standardized viral load reference method is not available. To test for infectivity of ZIKV in semen, ZIKV isolation will be attempted in semen samples with a high viral ZIKV load (i.e. positive ZIKV PCR result and Ct-values below 30) by inoculation in Vero cells.

Primary outcomes

Measurement of the presence (with RT-PCR) of ZIKV in semen

Time frame: 6 months

Secondary outcomes

Measurement of the viral load (with ct values) of ZIKV in semen

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Trinidad and Tobago IVF and Fertility Centre

Other

Collaborators

Institute of Tropical Medicine, Belgium

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Dec 2, 2016
Registry last updated: May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed