Observational, Retrospective Analysis in HIV-1 Infected Patients. (ORASWIRAL)

NCT02708342 | Completed

• 1 other identifier: ORASWIRAL
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

RESEARCH METHODS Study Design Observational, Retrospective, Single-center, Single-arm Study of patients treated with raltegravir plus abacavir and lamivudine.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Durability of an antiretroviral regimen of raltegravir plus abacavir and lamivudine

  time to treatment failure through 96 weeks

Secondary Outcomes (22)

• Cumulative probability of virological failure

  through 96 weeks

• Proportion of patients with virological failure

  through 96 weeks

• Proportion of patients with treatment failure

  through 96 weeks

• Proportion of patients with more or equal to grade 2 abnormal laboratory tests

  through 96 weeks

• Change in Lymphocytes CD4+

  through 96 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient HIV-1 positive treated with raltegravir plus abacavir and lamivudine

You may qualify if:

• HIV-1 infected patients,
• age \> 18 years,
• Human leukocyte antigen (HLA) B5701-negative
• treatment-experienced patients with viral suppression (HIV-RNA \<50 copies/mL), who switched from any antiretroviral drug to raltegravir plus abacavir and lamivudine because of toxicity, convenience or other reasons
• At least one viral load assessed before and at least once after starting the study regimen.

You may not qualify if:

• Documented drug-resistance or virological failure to integrase inhibitors, abacavir or lamivudine before starting the study regimen.
• Pregnancy at the start of the study regimen.
• HBsAg positive.

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (5)

• Raffi F, Jaeger H, Quiros-Roldan E, Albrecht H, Belonosova E, Gatell JM, Baril JG, Domingo P, Brennan C, Almond S, Min S; extended SPRING-2 Study Group. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2013 Nov;13(11):927-35. doi: 10.1016/S1473-3099(13)70257-3. Epub 2013 Sep 25.

  PMID: 24074642 RESULT

• Suzuki A, Uehara Y, Saita M, Inui A, Isonuma H, Naito T. Raltegravir and Abacavir/Lamivudine in Japanese Treatment-Naive and Treatment-Experienced Patients with HIV Infection: a 48-Week Retrospective Pilot Analysis. Jpn J Infect Dis. 2016;69(1):33-8. doi: 10.7883/yoken.JJID.2014.236. Epub 2015 May 12.

  PMID: 25971320 RESULT

• Fabbiani M, Mondi A, Colafigli M, D'Ettorre G, Paoletti F, D'Avino A, Ciccarelli N, Sidella L, Murri R, Fortuna S, Vullo V, Cauda R, De Luca A, Di Giambenedetto S. Safety and efficacy of treatment switch to raltegravir plus tenofovir/emtricitabine or abacavir/lamivudine in patients with optimal virological control: 48-week results from a randomized pilot study (Raltegravir Switch for Toxicity or Adverse Events, RASTA Study). Scand J Infect Dis. 2014 Jan;46(1):34-45. doi: 10.3109/00365548.2013.840920. Epub 2013 Oct 28.

  PMID: 24161018 RESULT

• Martinez E, d'Albuquerque PM, Perez I, Pich J, Gatell JM. Abacavir/lamivudine versus tenofovir/emtricitabine in virologically suppressed patients switching from ritonavir-boosted protease inhibitors to raltegravir. AIDS Res Hum Retroviruses. 2013 Feb;29(2):235-41. doi: 10.1089/AID.2012.0150. Epub 2012 Sep 24.

  PMID: 22916715 RESULT

• Young B, Vanig T, Dejesus E, Hawkins T, St Clair M, Yau L, Ha B, Shield Study Team. A pilot study of abacavir/lamivudine and raltegravir in antiretroviral-naive HIV-1-infected patients: 48-week results of the SHIELD trial. HIV Clin Trials. 2010 Sep-Oct;11(5):260-9. doi: 10.1310/hct1105-260.

  PMID: 21126956 RESULT

Related Links

• Italian Guidelines for the management of antiretroviral therapy of the subjects with HIV-1 infection.

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - (PI and Promoter Professor Adriano Lazzarin)

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 15, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share