HIV-1-infectionMIAMINCT03183154
Mathematical Modeling of the HIV Transmission Risk After Initiation of Antiretroviral Therapy in naïve HIV-infected
An observational study of HIV-1-infection, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV-1-infection
- How many people
- 1,831 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2016to 30 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: naïve HIV-infected MSM
Who may be able to join
- naïve HIV-infected MSM
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Juan Berenguer, PhD, +34620038850
About this study
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.
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.
Read the 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.
- Conditions
- HIV-1-infection
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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
Measured: 24 weeks after initiation of cART
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start1 Aug 2016
- Primary completion30 Sep 2017 (estimated)
- Study completion30 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,831 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, J Parrondo Health, Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183154
- Sponsor's protocol ID
- FIBHGM-EONC001-2016
- Acronym
- MIAMI
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2017
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31323075
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03183154
- Acronym / sponsor ID
- MIAMI / FIBHGM-EONC001-2016
- Conditions
- HIV-1-infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,831 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, J Parrondo Health, Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 30 Sep 2017 (estimated)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- naïve HIV-infected MSM
Key inclusion criteria (1 listed)
- naïve HIV-infected MSM
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Derived from this study: PubMed 31323075Berenguer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Berenguer, PhD (+34620038850, jbb4@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 24 weeks after initiation of cART). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03183154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.