Simplification From Protease Inhibitors to Raltegravir

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RAL QD 800 mg/24 hs

Group Type EXPERIMENTAL

Raltegravir (Use RAL as a simplification strategy)

Intervention Type DRUG

RAL QD: RAL 800 mg/24 hs

RAL BID 400 mg/12 hs

Group Type ACTIVE_COMPARATOR

Raltegravir (Use RAL as a simplification strategy)

Intervention Type DRUG

RAL BID 400 mg/12 hs

RAL BID to QD

Group Type EXPERIMENTAL

Raltegravir (Use RAL as a simplification strategy)

Intervention Type DRUG

RAL BID to QD

Interventions

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Raltegravir (Use RAL as a simplification strategy)

RAL QD: RAL 800 mg/24 hs

Intervention Type DRUG

Raltegravir (Use RAL as a simplification strategy)

RAL BID 400 mg/12 hs

Intervention Type DRUG

Raltegravir (Use RAL as a simplification strategy)

RAL BID to QD

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No