Efficacy of Raltegravir in a Large Urban HIV Clinical Population in Milan - Full Text View

Purpose

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.

Condition
HIV Infections


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Retrospective
Official Title:	Efficacy of Raltegravir in a Large Urban HIV Clinic Population in Milan (Efficacy of Raltegravir in a Large Urban HIV Clinic Setting)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Raltegravir Raltegravir potassium

U.S. FDA Resources

Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:

Real-Life [ Time Frame: baseline and week 48 ] [ Designated as safety issue: No ]
Primary endpoint is the proportion of patients with HIV-1 RNA<50 copies/ml at weeks 48 after treatment initiation (baseline).

Secondary Outcome Measures:

Real-Life [ Time Frame: baseline and week 48 ] [ Designated as safety issue: No ]
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


Enrollment:	400
Study Start Date:	December 2011
Study Completion Date:	December 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Raltegravir group This study will include 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. A control group will be used for the evaluation of the primary and secondary objectives in comparison to patients treated with raltegravir (study patients). The control group will be constituted by subjects who never received raltegravir, matched (in a ratio 1:3) with the study subjects by gender, age (± 3 years), CD4+ cells counts (± 50 cells) and HCV co-infection status yes/no). For control patients, the last antiretroviral regimen prescribed will be considered.

Groups/Cohorts

Raltegravir group

This study will include 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.

A control group will be used for the evaluation of the primary and secondary objectives in comparison to patients treated with raltegravir (study patients). The control group will be constituted by subjects who never received raltegravir, matched (in a ratio 1:3) with the study subjects by gender, age (± 3 years), CD4+ cells counts (± 50 cells) and HCV co-infection status yes/no). For control patients, the last antiretroviral regimen prescribed will be considered.

Eligibility


Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

This study will include 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.

A control group will be used for the evaluation of the primary and secondary objectives in comparison to patients treated with raltegravir (study patients). The control group will be constituted by subjects who never received raltegravir, matched (in a ratio 1:3) with the study subjects by gender, age (± 3 years), CD4+ cells counts (± 50 cells) and HCV co-infection status yes/no). For control patients, the last antiretroviral regimen prescribed will be considered.

Criteria

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:

None

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467349

Locations


Italy
Infectious Diseases Department
Milan, Italy, 20127

Sponsors and Collaborators

Università Vita-Salute San Raffaele

Ospedale San Raffaele

Investigators


Principal Investigator:	Massimo Clementi, Prof.	Università Vita-Salute

More Information

Publications:

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.

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.


Responsible Party:	Elisabetta Carini, Professor Massimo Clementi, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:	NCT01467349 History of Changes
Other Study ID Numbers:	Real-Life Study, n.a., Real-Life
Study First Received:	November 3, 2011
Last Updated:	February 8, 2013
Health Authority:	Italy: Ethics Committee

Keywords provided by Università Vita-Salute San Raffaele:


Raltegravir efficacy safety raltegravir-containing regimens HIV urban clinic setting

ClinicalTrials.gov processed this record on March 02, 2015

Efficacy of Raltegravir in a Large Urban HIV Clinical Population in Milan (Real-Life)