Efficacy of Raltegravir in a Large Urban HIV Clinical Population in Milan

HIV Infections Clinical Trial

— Real-Life  

Official title:

Efficacy of Raltegravir in a Large Urban HIV Clinic Population in Milan (Efficacy of Raltegravir in a Large Urban HIV Clinic Setting)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467349
• Other study ID #: Real-Life Study
• Secondary ID: n.a.Real-Life
• Status: Completed
• Phase: N/A
• First received: November 3, 2011
• Last updated: February 8, 2013
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: Università Vita-Salute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This will be a retrospective analysis of efficacy, safety and tolerability of raltegravir as part of an optimized therapy in a clinical setting.

Follow-up is calculated from the treatment initiation (with or without raltegravir) up to the date of discontinuation of the considered regimen or the date of last visit or the date of lost to follow-up, whichever came first.

The Aim of the study is to evaluate the efficacy and safety of raltegravir-containing regimens in a urban clinic setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Subjects who received raltegravir and were previously exposed to NRTIs, NNRTIs, PIs, regardless of the stage of HIV disease at the start of the treatment.

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Italy	Infectious Diseases Department	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele	Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Lennox JL, Dejesus E, Berger DS, Lazzarin A, Pollard RB, Ramalho Madruga JV, Zhao J, Wan H, Gilbert CL, Teppler H, Rodgers AJ, Barnard RJ, Miller MD, Dinubile MJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK Investigators. Raltegravir versus Efavirenz regimens in treatment-naive HIV-1-infected patients: 96-week efficacy, durability, subgroup, safety, and metabolic analyses. J Acquir Immune Defic Syndr. 2010 Sep;55(1):39-48. doi: 10.1097/QAI.0b013e3181da1287. Erratum in: J Acquir Immune Defic Syndr. 2011 Dec 1;58(4):e120. Dosage error in article text. — View Citation

Steigbigel RT, Cooper DA, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Nguyen BY, Teppler H; BENCHMRK Study Teams. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):339-54. doi: 10.1056/NEJMoa0708975. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-Life	Primary endpoint is the proportion of patients with HIV-1 RNA<50 copies/ml at weeks 48 after treatment initiation (baseline).	baseline and week 48	No
Secondary	Real-Life	Secondary endpoints are: Proportion of patients with HIV-1 RNA<50 copies/ml at the end of the treatment/last available visit; Proportion of patients with HIV-1 RNA<400 copies/ml at week 48; Increase in absolute CD4 cell count from baseline; Frequency of side effects associated with raltegravir treatment; Frequency of reasons for starting/stopping raltegravir treatment	baseline and week 48	No