Switching From PI to RALtegravir in HIV Stable Patients (SPIRAL)
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ClinicalTrials.gov Identifier: NCT00528892 |
Recruitment Status
:
Completed
First Posted
: September 12, 2007
Last Update Posted
: March 31, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Raltegravir Drug: boosted PI | Phase 3 |
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 |

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
|
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00528892
Spain | |
Hospital Clinic | |
Barcelona, Spain, 08036 |
Principal Investigator: | Jose M Gatell, MD | Hospital Clinic of Barcelona |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jose M Gatell, Hospital Clinic barcelona |
ClinicalTrials.gov Identifier: | NCT00528892 History of Changes |
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:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Raltegravir Potassium HIV Protease Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors HIV Integrase Inhibitors Integrase Inhibitors |