Clinical trial NCT03183154: Mathematical Modeling of the HIV Transmission Risk After Initiation of Antiretroviral Therapy in naïve HIV-infected
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV-1-infection
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: J Parrondo Health
name: Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
First posted: 2017-06-09
Enrollment: 1831
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: naïve HIV-infected MSM

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.

Eligibility criteria: Inclusion Criteria:

* naïve HIV-infected MSM

Exclusion Criteria:

* none

Primary outcomes:
measure: 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
timeFrame: 24 weeks after initiation of cART
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
Study officials:
References:
citation: 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.