NCT00234923

Brief Summary

The purpose of this pilot study is to obtain a preliminary assessment of the antiviral activity and tolerability of Kaletra single agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P25-P50 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Last Updated

April 3, 2008

Status Verified

April 1, 2008

Enrollment Period

3.5 years

First QC Date

September 13, 2005

Last Update Submit

April 1, 2008

Conditions

HIV Infection

Keywords

HIV InfectionKaletraLopinavirRitonavirTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • Antiviral efficacy by HIV RNA

    48 Weeks

Secondary Outcomes (2)

  • Arm comparisons: CD4 evolution, occurrence of HIV protease and RT mutation, occurrence of AIDS clinical events, safety of NRTI-sparing vs. a PI with 2 NRTIs regimen: clinical and biological tolerance, patient's adherence and quality of life.

    48 weeks

  • To assess in the LPV/r single-drug regimen arm: virological control, CD4 evolution, safety

    96 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Kaletra Monotherapy: lopinavir/ritonavir

Drug: lopinavir/ritonavir

2

ACTIVE COMPARATOR

Kaletra based triple therapy: lopinavir/ritonavir + lamivudine/zidovudine

Drug: lopinavir/ritonavirDrug: lamivudine/zidovudine

Interventions

lopinavir/ritonavirDRUG

400 mg lopinavir/ 100 mg ritonavir, BID

Also known as: ABT-378, Kaletra
12
lamivudine/zidovudineDRUG

300mg lamivudine/150mg zidovudine, BID

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Antiretroviral naïve
  • HIV RNA \<100,000 copies/mL
  • CD4 cell count \>100 cells/mL at screening
  • with Karnofsky Score \> 70
  • If female,
  • non-pregnant and
  • not breastfeeding
  • No AIDS opportunistic infection within 30 days of screening

You may not qualify if:

  • Subject with an HIV primo-infection status
  • Recent history of drug and/or alcohol abuse
  • History of psychiatric illness
  • If presence of the following mutations :
  • in the protease : one among 32,47,48,50,82,84,90
  • OR more than 3 mutations from the other points of the LPV mutation score:10,20,24,46,53,54,63,71
  • in the reverse transcriptase : 215 or 184.
  • If abnormal laboratory results such as :
  • Hb\<8 g/dl
  • Absolute neutrophil count\<750 cells/µl
  • Platelet count\<50 000/ml

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Tran TA, Ghosn J, Avettand-Fenoel V, Hendel-Chavez H, de Goer de Herve MG, Cohen-Codar I, Rouzioux C, Delfraissy JF, Taoufik Y. Residual HIV-1 replication may impact immune recovery in patients on first-line lopinavir/ritonavir monotherapy. J Antimicrob Chemother. 2015 Sep;70(9):2627-31. doi: 10.1093/jac/dkv138. Epub 2015 May 28.

    PMID: 26023212DERIVED

  • Ghosn J, Flandre P, Cohen-Codar I, Girard PM, Chaix ML, Raffi F, Dellamonica P, Ngovan P, Norton M, Delfraissy JF; MONARK Study Group. Long-term (96-week) follow-up of antiretroviral-naive HIV-infected patients treated with first-line lopinavir/ritonavir monotherapy in the MONARK trial. HIV Med. 2010 Feb;11(2):137-42. doi: 10.1111/j.1468-1293.2009.00752.x. Epub 2009 Aug 13.

    PMID: 19682100DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Lopinavirlopinavir-ritonavir drug combinationlamivudine, zidovudine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Global Medical Information

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

October 10, 2005

Study Start

August 1, 2003

Primary Completion

February 1, 2007

Last Updated

April 3, 2008

Record last verified: 2008-04