Mathematical Modeling of the HIV Transmission Risk After Initiation of Antiretroviral Therapy in naïve HIV-infected

• Conditions: HIV-1-infection

• Registration Number: NCT03183154
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

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.

Detailed Description

The HIV epidemic among men who have sex with men (MSM) continues to expand in low, middle, and high-income countries. The disproportionate HIV disease burden in MSM is explained largely by the high per act and per-partner transmission probability of HIV transmission in receptive anal sex . Current strategies are inadequate to control HIV spread among MSM; much more vigorous prevention efforts are required, including the early initiation of antiretroviral therapy (ART) that has been shown to reduce the rates of sexual transmission of HIV-1 and the adaptation and expanded use of pre-exposure prophylaxis (PrEP) to prevent the acquisition of HIV-1 infection .

Initiation of ART with regimens based on integrase strand transfer inhibitors (INSTI) is associated with a faster decline in HIV-RNA load than what is observed with regimens based on non-nucleoside transcriptase inhibitors (nnRTI), and protease inhibitors (PI). The clinical impact of this finding is unknown although clinical anecdotes suggest that it may it may cause a rapid decline in HIV RNA in women presenting with HIV in late pregnancy.

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.

Study Timeline

• Study Start: 2016-08-01
• Status Verified: 2017-06
• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-09
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 1831

Inclusion Criteria

• naïve HIV-infected MSM

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain