An Observational Retrospective Database Analysis to Evaluate Raltegravir Based-regimens, Including NUC-sparing Regimens, in Aged HIV Patients.(RalAge) (RalAge2)
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|ClinicalTrials.gov Identifier: NCT03579485|
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : July 6, 2018
This is an observational retrospective cohort in real world to describe RAL data, including NUC-sparing regimens, in aged HIV patients. It is a phase IV study.
90 patients will be enrolled from the Department of Public Health and Infectious Diseases of "Sapienza" University of Rome.
In this retrospective analysis all naïve patients on raltegravir-based regimens and all patients switched to raltegravir-based regimens will be considered.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Official Title:||An Observational Retrospective Database Analysis to Evaluate Raltegravir Based-regimens, Including NUC-sparing Regimens, in Aged HIV Patients.(RalAge)|
|Actual Study Start Date :||January 31, 2018|
|Estimated Primary Completion Date :||January 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
aging HIV positive patients
HIV-1 infected patients, aged ≥ 60 years old, naive patients receiving raltegravir based-regimen, including Nuc-sparing regimens or experienced patients with virological suppression (HIV-1 RNA<50 copies) who had switched from any antiretroviral drug to raltegravir-based regimens (including Nuc-sparing regimens) because of toxicity, convenience or other reasons.
- HIV-1 viral load [ Time Frame: 12 months ]HIV-1 viral load < 50 copies/mL
- CD4+ T-cell counts [ Time Frame: 12 months ]Change from Baseline in CD4+ T-cell counts (delta)
- CD8 cell counts [ Time Frame: 12 months ]Change from Baseline in CD8 cell counts (delta)
- CD4/ CD8 ratio [ Time Frame: 12 months ]Change from Baseline in CD4/ CD8 ratio (delta)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579485
|Contact: Gabriella d'Ettorre, MD, PhDemail@example.com|
|Contact: vincenzo Vullo, MDfirstname.lastname@example.org|
|Policlinico Umberto I Hospital||Recruiting|
|Rome, Italy, 00155|
|Contact: Gabriella D'Ettorre email@example.com|
|Principal Investigator: Gabriella D'Ettorre|
|Principal Investigator: Vincenzo Vullo|
|Sub-Investigator: Giancarlo Ceccarelli|