- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03183154
Mathematical Modeling of the HIV Transmission Risk After Initiation of Antiretroviral Therapy in naïve HIV-infected (MIAMI)
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 Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Madrid, Spain, 28007
- Recruiting
- Hospital General Universitario Gregorio Marañón
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Contact:
- Juan Berenguer, PhD
- Phone Number: +34620038850
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- naïve HIV-infected MSM
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 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
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24 weeks after initiation of cART
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FIBHGM-EONC001-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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