Simplification From Protease Inhibitors to Raltegravir (ODIS)

Hospital Carlos III, Madrid

Status and phase: Unknown; Phase 4

Conditions: HIV Infections

Treatments: Drug: Raltegravir (Use RAL as a simplification strategy)

Study type: Interventional

Funder types: Other

Identifiers

NCT00941083

HC0509

Details and patient eligibility

About

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).

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

RAL QD 800 mg/24 hs

Experimental group

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)

RAL BID 400 mg/12 hs

Active Comparator group

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)

RAL BID to QD

Experimental group

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)