Clinical trial NCT00234923: Efficacy and Safety of Kaletra Monotheraphy Compared to Kaletra Based Triple Therapy to Treat HIV in Antiretroviral Naїve Patients
Official title: A Pilot, Open-Label, Randomized, Comparative Study of the Antiviral Efficacy of Lopinavir/Ritonavir Single-Drug Regimen Versus Lopinavir/Ritonavir in Combination With Lamivudine/Zidovudine in Antiretroviral Naïve Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infection
Keywords: HIV Infection
Kaletra
Lopinavir
Ritonavir
Treatment Naive
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


Eligibility criteria: 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

Primary outcomes:
measure: Antiviral efficacy by HIV RNA
timeFrame: 48 Weeks
Secondary outcomes:
measure: 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.
timeFrame: 48 weeks
measure: To assess in the LPV/r single-drug regimen arm: virological control, CD4 evolution, safety
timeFrame: 96 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Global Medical Information
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.