Switching From PI to RALtegravir in HIV Stable Patients (SPIRAL)

March 30, 2010 updated by: Hospital Clinic of Barcelona

An Open-label, Randomized, 48-Week Study to Assess the Safety, Tolerability and Activity of Raltegravir When Replacing the Ritonavir-boosted PI Component of HAART in HIV-Infected Individuals With Viral Load Suppression on a Ritonavir-Boosted PI Containing Regimen.

The investigators hypothesis is that switching from a ritonavir-boosted PI to raltegravir may be associated with an at least non-inferior effectiveness, virological response and safety, and even a better tolerability profile with regard to lipid metabolism, insulin resistance, body fat distribution as compared with continuation of the baseline regimen in HIV-1 seropositive males or females at least 18 years of age and older on ritonavir-boosted PI plus at least 2 other drugs and plasma viral RNA below 50 copies/mL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

282

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Patient is a male or female at least 18 years of age.
  • Women of childbearing potential must have a negative serum pregnancy test (HCG) within 10 days prior to randomization into the study.
  • Patients must use adequate birth control measures (barrier method.)
  • Patients must be HIV 1 seropositive using standard diagnostic criteria.
  • Patients must have two plasma viral RNA measurements below detection limits with the routine ultrasensitive method used at each participating site (at least <50 copies/mL) within 180 days prior to randomization into this study.
  • Patients must be on continuous therapy with HAART consisting of a ritonavir-boosted protease-inhibitor (PI) and at least two other antiretroviral agents for at least 6 months prior to randomization into this study, with no planned drug changes in the following 12 months. Boosted PIs can be indinavir, fosamprenavir, saquinavir, lopinavir, atazanavir, tipranavir or darunavir.
  • Patients must be considered clinically stable, in the opinion of the investigator, at the time of entry into the study; i.e., clinical status and all chronic medications should be unchanged for at least 14 days prior to randomization. Patients currently receiving treatment for an opportunistic infection may be allowed into the study as long as the above criteria are met. Prophylaxis for opportunistic infections consistent with standard treatment is permissible. .

  • The following laboratory values must be obtained within 2-4 weeks of randomization into the study:

    • Hemoglobin >8.0 g/dL.
    • Absolute neutrophil count > 750/mm3
    • Platelet count > 50,000/ mm3
    • Creatinine < 2.0 mg/dL.
    • Transaminases (ALAT, ASAT) <5xULN

Exclusion Criteria:

  • Pregnancy or breast feeding or women planning pregnancy during the study duration.
  • Patients on ART regimens not likely to be maintained during the whole study duration
  • Prior use of HIV integrase inhibitors.
  • Use of any investigational agents (other than ART on expanded access programme) within 90 days of randomization.
  • Alcohol or substance abuse which in the opinion of the investigator would interfere with patient compliance or safety.
  • Patients with an active opportunistic infection or malignancy. Patients with a chronic, stable opportunistic infection will be allowed to enter this study.
  • Any condition or history of any illness which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the patient.
  • Any patient with a diagnosis of visceral Kaposi's sarcoma. Patients with lymphedema secondary to cutaneous Kaposi's sarcoma, or with cutaneous or palatal Kaposi's sarcoma that has been treated with systemic immunosuppressive therapy must also be excluded.
  • Any patient with a diagnosis of acute hepatitis due to any cause. Patients with chronic hepatitis including chronic hepatitis B surface antigenemia chronic hepatitis C may enter the study as long as they have stable liver function tests and meet all inclusion criteria. Patients with acute exacerbations of chronic hepatitis are excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Switch current boosted-PI to raltegravir 400 mg BID.
Drug: Raltegravir
switching PI to raltegravir
Active Comparator: 2
Continue current regimen (ritonavir-boosted PI plus at least 2 other drugs)
Drug: boosted PI
continue on boosted-PI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients with treatment failure (i.e.: those with viral failure, developing new CDC-C events, switching assigned treatment for any cause, withdrawing consent, being lost to follow-up or dying)
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients with viral failure while on assigned treatment (defined as two consecutive plasma HIV-RNA below detection limits)
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Jose M Gatell, MD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

September 10, 2007

First Submitted That Met QC Criteria

September 11, 2007

First Posted (Estimate)

September 12, 2007

Study Record Updates

Last Update Posted (Estimate)

March 31, 2010

Last Update Submitted That Met QC Criteria

March 30, 2010

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPIRAL
  • EUDRACT: 2007-003401-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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