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An Observational Retrospective Database Analysis to Evaluate Raltegravir Based-regimens in Aged HIV Patients (RalAge)

NCT02765776 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2018-06-28

No results posted yet for this study

Summary

RAL is considered one of the better-tolerated antiretroviral medications, due to limited side effects and few long-term safety concerns. Five-year clinical trial outcomes and clinical experience have demonstrated durable virologic suppression in both treatment-naïve and treatment-experienced patients, including patients with extensive antiretroviral history and documented antiretroviral resistance. Studies have also exhibited low adverse effect rates and reliable long-term safety lending to improved tolerance. Several trials have evaluated the reduction in adverse effects in patients switched from various antiretroviral agents to RAL. Treatment-naïve studies have demonstrated a lipid-neutral effect in patients on RAL-containing regimens. When transitioning patients from a ritonavir-boosted PI regimen, statistically significant decreases in total plasma cholesterol, low-density lipoprotein, and triglycerides were demonstrated. Given its negligible interaction with the cytochrome P450 system, RAL displays minimal drug-drug interactions, making it a good option for ageing patients on multiple medications.

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. More than 4000 HIV patients are followed at this Department of Public Health and Infectious Diseases of "Sapienza" University of Rome. More than 50% of these patients are ≥ 50 years. From 10 to 12% are treated with a raltegravir based- regimen.

The primary endpoint will be the description of the proportion of participants with an HIV-1 viral load \< 50 copies/mL.

The secondary endpoints will be:

* Change from Baseline in CD4+ T-cell counts, CD8 cell counts, CD4/ CD8 ratio
* Proportion of subjects with laboratory alterations
* Proportion of patients with adverse events (AE), serious adverse events (SAE), also according to their severity

Conditions

Interventions

OTHER

Observational retrospective cohort to describe RAL data

This is an observational retrospective cohort in real world to describe RAL data, including NUC-sparing regimens, in aged HIV patients. In this retrospective analysis all naïve patients on raltegravir-based regimens and all patients switched to raltegravir-based regimens will be considered. For raltegravir-based regimens the investigators mean raltegravir as third agent in a triple regimen with NRTIs and also raltegravir-based regimens in NUC-sparing therapies. Data will be collected from medical records. The Time horizon for patient follow-up for outcome is at least 12 months.

Sponsors & Collaborators

  • University of Roma La Sapienza

    collaborator OTHER

  • Azienda Policlinico Umberto I

    lead OTHER

Principal Investigators

  • Gabriella d'Ettorre, MD, PhD · Azienda Policlinico Umberto I (Rome)

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-09-30
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02765776 on ClinicalTrials.gov