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

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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03183154
Acronym
MIAMI
Enrollment
1831
Registered
2017-06-09
Start date
2016-08-01
Completion date
2017-09-30
Last updated
2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1-infection

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.

Interventions

OTHERno intervention

no intervention

Sponsors

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

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* naïve HIV-infected MSM

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
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 PI24 weeks after initiation of cART1\. 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

Countries

Spain

Contacts

Primary ContactJuan Berenguer, PhD
jbb4@me.com+34620038850

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026