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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00528892
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : March 31, 2010
Information provided by:
Hospital Clinic of Barcelona

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Raltegravir Drug: boosted PI Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00528892

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Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
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Principal Investigator: Jose M Gatell, MD Hospital Clinic of Barcelona
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jose M Gatell, Hospital Clinic barcelona Identifier: NCT00528892    
Other Study ID Numbers: SPIRAL
EUDRACT: 2007-003401-27
First Posted: September 12, 2007    Key Record Dates
Last Update Posted: March 31, 2010
Last Verified: May 2008
Keywords provided by Hospital Clinic of Barcelona:
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action