NCT03183154

Brief Summary

The objective of this study is to explore the impact of initiation of ART with different regimens in naïve MSM (in the setting of acute and chronic HIV-infection) on the probability of transmission of HIV by mathematical modeling.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,831

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

June 8, 2017

Last Update Submit

June 9, 2017

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

  • To estimate the probability of HIV transmission during the first 24 weeks after initiation of cART in naïve HIV-infected MSM (in the setting of acute and chronic HIV-infection), with regimens based on nnRTI, INSTI, and PI

    1\. To estimate the probability of HIV transmission during the first 24 weeks after initiation of cART in naïve HIV-infected MSM (in the setting of acute and chronic HIV-infection), with regimens based on nnRTI, INSTI, and PI

    24 weeks after initiation of cART

Interventions

no interventionOTHER

no intervention

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmen who have sex with men (MSM)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

naïve HIV-infected MSM

You may qualify if:

  • naïve HIV-infected MSM

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

Related Publications (1)

  • Berenguer J, Parrondo J, Landovitz RJ. Mathematical modeling of HIV-1 transmission risk from condomless anal intercourse in HIV-infected MSM by the type of initial ART. PLoS One. 2019 Jul 19;14(7):e0219802. doi: 10.1371/journal.pone.0219802. eCollection 2019.

    PMID: 31323075DERIVED

Central Study Contacts

Juan Berenguer, PhD

CONTACT

+34620038850jbb4@me.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2017

First Posted

June 9, 2017

Study Start

August 1, 2016

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

June 12, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)