Induction-maintenance of Lopinavir/r in HIV-infected Subjects

NCT ID: NCT00159224

Last Updated: 2015-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2009-12-31

Brief Summary

This study will assess the safety, tolerability and antiviral activity of a simplified PI-based treatment regimen (Kaletra,ä) compared to conventional HAART regimens in patients infected with HIV-1 who are on their first boosted-PI antiretroviral treatment regimen.

The potency of the antiviral activity of Kaletra has been clearly demonstrated in a wide spectrum of patients in a number of different clinical trials.6-9 The durable viral suppression seen after 4 years of therapy10 proves that it can provide effective, long-term treatment for people with HIV-1.

Data from one of these trials (M97-720),6 an ongoing Phase II study of lopinavir/ritonavir in combination with NRTIs suggests there may be a role for monoclass therapy with Kaletra in the treatment of HIV-1-infection.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lopinavir/ritonavir monotherapy

Patients with undetectable viral load while on 1st line ARV therapy will be randomized to the expermental arm: Lopinavir/ritonavir monotherapy

Group Type: EXPERIMENTAL

Lopinavir/ritonavir simplification strategy

Intervention Type: DRUG

Simplification

Lopinavir/Ritonavir plus 2 NRTIs

Patients randomized to this arm will continue with standard of care triple therapy, based on Lopinavir/Ritonavir plus 2 NRTIs

Group Type: ACTIVE_COMPARATOR

Lopinavir/ritonavir simplification strategy

Intervention Type: DRUG

Simplification

Interventions

Lopinavir/ritonavir simplification strategy

Simplification

Intervention Type: DRUG

Other Intervention Names

Kaletra monotherapy simplification strategy

Eligibility Criteria

Inclusion Criteria

• Subject has confirmed his or her willingness to participate in this study after being informed of all aspects of the trial that are relevant to his or her decision to take part, by signing and dating the IRB / IEC approved informed consent form.
• Subject is HIV positive and on their first antiretroviral treatment regimen, based on any two NRTIs plus lopinavir/ritonavir or a ritonavir-boosted PI combination. Subject must have had no previous exposure to other regimens.
• Subject has a viral load <50 copies/ml at the time of baseline evaluation for at least 6 months.
• Subject has a CD4 cell count ³ 100 cells/mm3.
• Subject is aged >18 years.
• Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
• Subject has not been treated for an active opportunistic infection within 30 days of screening.
• If female, subject has a negative pregnancy test and agrees to use, for the duration of the study, a barrier method of birth control that has a history of proven reliability as judged by the investigator.
• Subject does not require and agrees not to take, for the duration of the study, any medication that is contraindicated with any of the antiretroviral drugs in their treatment regimen. The subject agrees not to take any medication, including over-the-counter medicine, alcohol, or recreational drugs without the knowledge and permission of the principal investigator

Exclusion Criteria

• Subject has current uncontrolled substance abuse or psychiatric illness that could preclude compliance with the protocol.
• Subject has a viral load of > 50 copies/ml
• Subject is HBsAg +
• Subject has active tuberculosis or an opportunistic infection.
• Subject has active malignancy (except Kaposi's Sarcoma).
• Subject has liver failure as evidenced by ALT / AST > 5 x Upper Limit of Normal (ULN).
• Female subject is pregnant or lactating.
• Subject has received an investigational drug within 30 days prior to the initiation of the study.
• Subject has modified his/her antiretroviral therapy during the 3 months prior to baseline or is intending to do so during the course of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Fundación Huésped

OTHER

Sponsor Role: lead

Responsible Party

Pedro Cahn

Scientic Director, The Huesped Foundation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pedro E Cahn, MD, PhD

Role: STUDY_CHAIR

Fundacion Huesped, Buenos Aires, Argentina

Julio SG Montaner, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Isabel L Cassetti, MD

Role: PRINCIPAL_INVESTIGATOR

Helios Salud, Buenos Aires, Argentina

Juan Sierra Madero, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricio Salvador Zurbaran, Mexico

Locations

Helios Salud

Buenos Aires, , Argentina

Fundacion Huesped

Buenos Aires, , Argentina

University of British Columbia

Vancouver, British Columbia, Canada

Instituto Nacional de Ciencias Medicas y Nutrición "Salvador Zubirán

Mexico City, , Mexico

Countries

Argentina; Canada; Mexico

References

Cahn P, Montaner J, Junod P, Patterson P, Krolewiecki A, Andrade-Villanueva J, Cassetti I, Sierra-Madero J, Casiro AD, Bortolozzi R, Lupo SH, Longo N, Rampakakis E, Ackad N, Sampalis JS. Pilot, randomized study assessing safety, tolerability and efficacy of simplified LPV/r maintenance therapy in HIV patients on the 1 PI-based regimen. PLoS One. 2011;6(8):e23726. doi: 10.1371/journal.pone.0023726. Epub 2011 Aug 19.

Reference Type: DERIVED

PMID: 21886816 (View on PubMed)

Other Identifiers

ACA-ARGE-04-001

Identifier Type: -

Identifier Source: org_study_id