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Efficacy and Safety of Kaletra Monotheraphy Compared to Kaletra Based Triple Therapy to Treat HIV in Antiretroviral Naїve Patients

NCT ID: NCT00234923

Last Updated: 2008-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Brief Summary

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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

Detailed Description

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Conditions

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HIV Infection

Keywords

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HIV Infection Kaletra Lopinavir Ritonavir Treatment Naive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Kaletra Monotherapy: lopinavir/ritonavir

Group Type ACTIVE_COMPARATOR

lopinavir/ritonavir

Intervention Type DRUG

400 mg lopinavir/ 100 mg ritonavir, BID

2

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

Group Type ACTIVE_COMPARATOR

lopinavir/ritonavir

Intervention Type DRUG

400 mg lopinavir/ 100 mg ritonavir, BID

lamivudine/zidovudine

Intervention Type DRUG

300mg lamivudine/150mg zidovudine, BID

Interventions

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lopinavir/ritonavir

400 mg lopinavir/ 100 mg ritonavir, BID

Intervention Type DRUG

lamivudine/zidovudine

300mg lamivudine/150mg zidovudine, BID

Intervention Type DRUG

Other Intervention Names

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ABT-378 Kaletra

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Global Medical Information

Role: STUDY_DIRECTOR

Abbott

References

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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.

Reference Type DERIVED
PMID: 26023212 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19682100 (View on PubMed)

Other Identifiers

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EUDRACT: 2004-816-24

Identifier Type: -

Identifier Source: secondary_id

MONARK

Identifier Type: -

Identifier Source: secondary_id

FRAN-03-001

Identifier Type: -

Identifier Source: org_study_id