Simplification From Protease Inhibitors to Raltegravir (ODIS)

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

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).

Study Overview

• Status: Unknown
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Raltegravir (Use RAL as a simplification strategy); Drug: Raltegravir (Use RAL as a simplification strategy); Drug: Raltegravir (Use RAL as a simplification strategy)

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28029
    • Recruiting
    • Hospital Carlos III
    • Contact: Vicente Soriano, PhD; Phone Number: +34914532536; Email: vsoriano@dragonet.es
    • Principal Investigator: Vicente Soriano, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RAL QD 800 mg/24 hs	Drug: Raltegravir (Use RAL as a simplification strategy); RAL QD: RAL 800 mg/24 hs; Drug: Raltegravir (Use RAL as a simplification strategy); RAL BID 400 mg/12 hs; Drug: Raltegravir (Use RAL as a simplification strategy); RAL BID to QD
Active Comparator: RAL BID 400 mg/12 hs	Drug: Raltegravir (Use RAL as a simplification strategy); RAL QD: RAL 800 mg/24 hs; Drug: Raltegravir (Use RAL as a simplification strategy); RAL BID 400 mg/12 hs; Drug: Raltegravir (Use RAL as a simplification strategy); RAL BID to QD
Experimental: RAL BID to QD	Drug: Raltegravir (Use RAL as a simplification strategy); RAL QD: RAL 800 mg/24 hs; Drug: Raltegravir (Use RAL as a simplification strategy); RAL BID 400 mg/12 hs; Drug: Raltegravir (Use RAL as a simplification strategy); RAL BID to QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
CD4 gains, lipid profile, adverse events,	24 weeks
Drug resistance mutations	24 weeks
Raltegravir through plasma levels and correlation with virological failure	24 weeks

Collaborators and Investigators

• Sponsor: Hospital Carlos III, Madrid
• Investigators: Principal Investigator: Vicente Soriano, Dr, Hospital Carlos III

Publications and helpful links

General Publications

• Vispo E, Barreiro P, Maida I, Mena A, Blanco F, Rodriguez-Novoa S, Morello J, Jimenez-Nacher I, Gonzalez-Lahoz J, Soriano V. Simplification from protease inhibitors to once- or twice-daily raltegravir: the ODIS trial. HIV Clin Trials. 2010 Jul-Aug;11(4):197-204. doi: 10.1310/hct1104-197.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: July 14, 2009
• First Submitted That Met QC Criteria: July 16, 2009
• First Posted (Estimate): July 17, 2009

Study Record Updates

• Last Update Posted (Estimate): September 10, 2009
• Last Update Submitted That Met QC Criteria: September 9, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Treatment Experienced; HIV-1 Infections; Simplification from protease inhibitors to raltegravir
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Raltegravir Potassium
• Other Study ID Numbers: HC0509