Hiv Clinical Trial
— RalAge2Official title:
An Observational Retrospective Database Analysis to Evaluate Raltegravir Based-regimens, Including NUC-sparing Regimens, in Aged HIV Patients.(RalAge)
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - signature of informed consent - HIV-1 infected patients, - aged = 60 years old - naive patients receiving raltegravir based-regimen, including Nuc-sparing regimens, - 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. Exclusion Criteria: - pregnancy |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Umberto I Hospital | Rome |
Lead Sponsor | Collaborator |
---|---|
Azienda Policlinico Umberto I |
Italy,
Pavone P, Giustini N, Fimiani C, Paoletti F, Falciano M, Salotti A, Di Sora F, Al Moghazi S, Mezzaroma I, Vullo V, d'Ettorre G. Long-Term Treatment With Raltegravir is Associated with Lower Triglycerides and Platelets Count in the Older HIV+ Population: Results from the Ral-Age Study. Curr HIV Res. 2017 Nov 23;15(5):355-360. doi: 10.2174/1570162X15666170927124558. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HIV-1 viral load | HIV-1 viral load < 50 copies/mL | 12 months | |
Secondary | CD4+ T-cell counts | Change from Baseline in CD4+ T-cell counts (delta) | 12 months | |
Secondary | CD8 cell counts | Change from Baseline in CD8 cell counts (delta) | 12 months | |
Secondary | CD4/ CD8 ratio | Change from Baseline in CD4/ CD8 ratio (delta) | 12 months |
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