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

HIV-1-infection Clinical Trial

— MIAMI  

Official title:

Mathematical Modeling of the HIV Transmission Risk During the First 24 Weeks After Initiation of Antiretroviral Therapy in naïve HIV-infected MSM: Comparison of INSTI-based Regimens vs. nnRTI and PI Based Regimens.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03183154
• Other study ID #: FIBHGM-EONC001-2016
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2017
• Last updated: June 9, 2017
• Start date: August 1, 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: June 2017
• Source: Hospital General Universitario Gregorio Marañon
• Contact: Juan Berenguer, PhD
• Phone: +34620038850
• Email: jbb4[@]me.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1831
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• naïve HIV-infected MSM

Exclusion Criteria:

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañón	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon	Fundación para la Investigación Biomédica del Hospital Gregorio Maranon, J Parrondo Health, University of California, Los Angeles

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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