Simplification From Protease Inhibitors to Raltegravir

HIV Infections Clinical Trial

— ODIS  

Official title:

Pilot, Open-label, Randomized, Single-center Study to Asses a Simplification Strategy From Protease Inhibitors to Raltegravir: Once Daily Isentress (ODIS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00941083
• Other study ID #: HC0509
• Status: Recruiting
• Phase: Phase 4
• First received: July 14, 2009
• Last updated: September 9, 2009
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: September 2009
• Source: Hospital Carlos III, Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically and immunologically. Moreover, it will be associated with significant improvements in the lipid profile in HIV patients with undetectable viremia on PIs. In this setting, RAL once a day (QD) will perform as well as RAL twice a day (BID).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV1 sero-positive using standard diagnostic criteria

• Plasma viral HIV-RNA below 50 copies/ml within 180 days prior to randomization

• On therapy with protease inhibitors both ritonavir-boosted or un-boosted for at least 6 months prior to study entry

Exclusion Criteria:

• Pregnancy or breast feeding

• Prior use of Integrase inhibitors

• Alcohol or substance abuse if according to the investigator opinion would interfere with compliance

• UIse of investigational medications within 30 days before study entry or during the trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Raltegravir (Use RAL as a simplification strategy)
RAL QD: RAL 800 mg/24 hs
• Raltegravir (Use RAL as a simplification strategy)
RAL BID 400 mg/12 hs
• Raltegravir (Use RAL as a simplification strategy)
RAL BID to QD

Locations

Country	Name	City	State
Spain	Hospital Carlos III	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Carlos III, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with plasma HIV-RNA < 50 copies/ml at week 24 in each arm (RAL QD, RAL BID, RAL BID to QD)		24 weeks	No
Secondary	CD4 gains, lipid profile, adverse events,		24 weeks	No
Secondary	Drug resistance mutations		24 weeks	No
Secondary	Raltegravir through plasma levels and correlation with virological failure		24 weeks	No