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

NCT00159224 | Completed Phase 4

• 1 other identifier: ACA-ARGE-04-001
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 4

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

Keywords

HIV; Simplification; Monotherapy; Treatment Naive; HIV-1 infection

Outcome Measures

Primary Outcomes (1)

• Proportion of patients remaining undetectable below 50 copies/mL at 48 weeks

  48 weeks

Study Arms (2)

Lopinavir/ritonavir monotherapy

EXPERIMENTAL

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

Drug: Lopinavir/ritonavir simplification strategy

Lopinavir/Ritonavir plus 2 NRTIs

ACTIVE COMPARATOR

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

Drug: Lopinavir/ritonavir simplification strategy

Interventions

Lopinavir/ritonavir simplification strategy DRUG

Simplification

Also known as: Kaletra monotherapy simplification strategy

Lopinavir/Ritonavir plus 2 NRTIs; Lopinavir/ritonavir monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Huésped: lead
• Abbott: collaborator

Study Sites (4)

Helios Salud

Buenos Aires, 1141, Argentina

Location

Fundacion Huesped

Buenos Aires, C1202ABB, Argentina

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

Instituto Nacional de Ciencias Medicas y Nutrición "Salvador Zubirán

Mexico City, Mexico

Location

Related Publications (1)

• 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.

  PMID: 21886816 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Lopinavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pedro E Cahn, MD, PhD

  Fundacion Huesped, Buenos Aires, Argentina

  STUDY CHAIR

• Julio SG Montaner, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Isabel L Cassetti, MD

  Helios Salud, Buenos Aires, Argentina

  PRINCIPAL INVESTIGATOR

• Juan Sierra Madero, MD

  Instituto Nacional de Ciencias Medicas y Nutricio Salvador Zurbaran, Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientic Director, The Huesped Foundation

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: April 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 7, 2015

Record last verified: 2015-09

Locations

AR (2); CA (1); ME (1)