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

NCT02765776 | Completed

• 1 other identifier: RalAge d'Ettorre 2016
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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

HIV

Keywords

Anti-HIV Drugs; Raltegravir Potassium; Aged; Retrospective Study; Medical Records

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with an HIV-1 viral load < 50 copies/mL

  12 months

Secondary Outcomes (30)

• Change from Baseline in CD4+ T-cell counts

  12 months

• Change from Baseline in CD8+ t-cell counts, CD8 cell counts

  12 months

• Change from Baseline in CD4/ CD8 ratio

  12 months

• Proportion of patients with adverse events (AE), serious adverse events (SAE), also according to their severity

  12 months

• demographics (age, sex, race)

  12 months

Interventions

Observational retrospective cohort to describe RAL data OTHER

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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. Raltegravir initiation is equivalent to baseline. All consecutive patients fulfilling the inclusion criteria are considered eligible.

You may qualify if:

• 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.

Sponsors & Collaborators

• Azienda Policlinico Umberto I: lead
• University of Roma La Sapienza: collaborator

Related Publications (4)

• Monteiro P, Perez I, Laguno M, Martinez-Rebollar M, Gonzalez-Cordon A, Lonca M, Mallolas J, Blanco JL, Gatell JM, Martinez E. Dual therapy with etravirine plus raltegravir for virologically suppressed HIV-infected patients: a pilot study. J Antimicrob Chemother. 2014 Mar;69(3):742-8. doi: 10.1093/jac/dkt406. Epub 2013 Oct 14.

  PMID: 24128667 BACKGROUND

• Liedtke MD, Tomlin CR, Lockhart SM, Miller MM, Rathbun RC. Long-term efficacy and safety of raltegravir in the management of HIV infection. Infect Drug Resist. 2014 Mar 18;7:73-84. doi: 10.2147/IDR.S40168. eCollection 2014.

  PMID: 24672249 BACKGROUND

• 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.

  PMID: 28969567 RESULT

• Santinelli L, Ceccarelli G, Borrazzo C, Celani L, Pavone P, Innocenti GP, Spagnolello O, Fimiani C, Ceci F, Di Sora F, Mezzaroma I, Mastroianni CM, d'Ettorre G. Real word outcomes associated with use of raltegravir in older people living with HIV: results from the 60 months follow-up of the RAL-age cohort. Expert Rev Anti Infect Ther. 2020 May;18(5):485-492. doi: 10.1080/14787210.2020.1733415. Epub 2020 Feb 25.

  PMID: 32096433 DERIVED

Study Officials

• Gabriella d'Ettorre, MD, PhD

  Azienda Policlinico Umberto I (Rome)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 9, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 28, 2018

Record last verified: 2016-05