Quantcast

Subscribe to:
POZ magazine
Newsletters
Join POZ: Facebook MySpace Twitter Pinterest
Tumblr Google+ Flickr Instagram
POZ Personals
Sign In / Join
Username:
Password:
Welcome, Guest. Please login or register.
October 25, 2014, 12:41:52 AM

Login with username, password and session length


Members
Stats
  • Total Posts: 643502
  • Total Topics: 48963
  • Online Today: 174
  • Online Ever: 585
  • (January 07, 2014, 02:31:47 PM)
Users Online

Welcome


Welcome to the POZ/AIDSmeds Community Forums, a round-the-clock discussion area for people with HIV/AIDS, their friends/family/caregivers, and others concerned about HIV/AIDS.  Click on the links below to browse our various forums; scroll down for a glance at the most recent posts; or join in the conversation yourself by registering on the left side of this page.

Privacy Warning:  Please realize that these forums are open to all, and are fully searchable via Google and other search engines. If you are HIV positive and disclose this in our forums, then it is almost the same thing as telling the whole world (or at least the World Wide Web). If this concerns you, then do not use a username or avatar that are self-identifying in any way. We do not allow the deletion of anything you post in these forums, so think before you post.

  • The information shared in these forums, by moderators and members, is designed to complement, not replace, the relationship between an individual and his/her own physician.

  • All members of these forums are, by default, not considered to be licensed medical providers. If otherwise, users must clearly define themselves as such.

  • Forums members must behave at all times with respect and honesty. Posting guidelines, including time-out and banning policies, have been established by the moderators of these forums. Click here for “Am I Infected?” posting guidelines. Click here for posting guidelines pertaining to all other POZ/AIDSmeds community forums.

  • We ask all forums members to provide references for health/medical/scientific information they provide, when it is not a personal experience being discussed. Please provide hyperlinks with full URLs or full citations of published works not available via the Internet. Additionally, all forums members must post information which are true and correct to their knowledge.

  • Product advertisement—including links; banners; editorial content; and clinical trial, study or survey participation—is strictly prohibited by forums members unless permission has been secured from POZ.

To change forums navigation language settings, click here (members only), Register now

Para cambiar sus preferencias de los foros en español, haz clic aquí (sólo miembros), Regístrate ahora

Finished Reading This? You can collapse this or any other box on this page by clicking the symbol in each box.

Author Topic: OK= Only Kaletra study. Jimenez Diaz Foundation.  (Read 2053 times)

0 Members and 1 Guest are viewing this topic.

Offline blondbeauty

  • Member
  • Posts: 1,784
OK= Only Kaletra study. Jimenez Diaz Foundation.
« on: February 17, 2007, 06:25:05 AM »
http://www.acceso.com/display_release.html?id=34209
http://www.ibanezyplaza.com/Prensa/NotaResult.asp?Id=262&Contacto=11
Translation of the article (not a very good one)
The therapy against the VIH with a single drug, world-wide hope by its effectiveness, security and saving Symposium on VIH/SIDA in the Jiménez Foundation Diaz · Spanish study OK confirms the expectations and it extends two years more with the new formulation of Kaletra in tablets The treatment of the VIH/SIDA with a single drug continues confirming the hopes deposited in him since Spanish study OK began (Only Kaletra): virológica effectiveness, absence of resistance, to reduce to the toxicity and considerable economic saving. Thus one has put of relief in the symposium "Advances in the antirretrovirales drug development and its strategic application in century XXI", celebrated in the Jiménez Foundation Diaz in the context of 2ª Meeting the International on Investigation Traslacional and Individualized Medicina. Doctor Jose Ramon You arrive, specialist in Infectious Diseases of the La Paz Hospital and coordinator of study OK, he exposed the good results of this study administering solely Kaletra as opposed to the triple standard therapy, and emphasized like very important the fact that the little failures registered throughout the test, after a year, are not offering resistance in the gene of the protease, reason why such patients can return without problems to the triple therapy that took previously. At the present time study OK has been prolonged until the 3 years, reason why the patients including in him are already acceding to the new formulation of Kaletra in tablets, a treatment but easy to follow by the patients. A determining saving The Jiménez Foundation Diaz is one of the 28 Spanish centers that at the moment participate in study OK. The Dr Miguel Górgolas, specialist in VIH of the Internal Medicine Department of the clinic, described his positive experience with the study. "the data which we have to 48 weeks indicate that the patients that receive the monotherapy present/display results of effectiveness very similar to which continues in triple therapy", it indicated. He in front of emphasized the absence of resistance of the VIH the drug, as well as to avoid the mitocondrial toxicity related to one of the drug families that come using until now in triple therapy. As far as the saving with this therapeutic strategy, "he would avoid more of the 50 percent of the present pharmaceutical cost by enfermo/año in the therapy as opposed to the VIH", according to the Dr Górgolas, with which it would mean for the scope of the VIH/SIDA, specially in the countries developing. At the present time the World-wide Organization of the Health indicates like therapy of election for the Third World the triple combination d4T + 3TC + Nevirapina, but already development of resistance is being observed that cause the failure of this therapy. As alternative the WHO along with recommends the election of a regime based on an Inhibitor of protease a small amount of ritonavir, another Inhibitor of protease that must keep in refrigerator (handicap important in many zones of the developing world). For that reason the monotherapy with Kaletra compressed considers a decisive advance in the fight against the VIH/SIDA.
 ______________________________________ If you wish to obtain imagene in hi-res of doctor Jose Ramon You arrive, specialist in Infectious Diseases of the La Paz Hospital and coordinator of study OK, you can free unload it in the Press room of www.ibanezyplaza.com ______________________________________ Brave Ibáñez&Plaza www.ibanezyplaza.com c Murillo, 81, 4ºC · 28003 Madrid · Telf. 91 553 74 62 · Fax 91 553 27 62 g.plaza.molina@ibanezyplaza.com · ediciones@ibanezyplaza.com More information in: www.ibanezyplaza.com
 


[attachment deleted by admin]
« Last Edit: February 17, 2007, 06:50:39 AM by blondbeauty »
The only member in these forums approved by WINBA: World International Nail and Beauty Association.
Epstein Barr +; CMV +; Toxoplasmosis +; HIV-1 +.
Counts when starting treatment:
V.L.:80.200 copies. CD4: 25%=503
Started Sustiva-Truvada 14/August/2006
Last V.L.count (Oct 2013): Undetectable
Last CD4 count (OCT 2013): 52%= 933

Offline Ihavehope

  • Member
  • Posts: 1,366
  • Yes, I'm a cry baby, AND WHAT?
Re: OK= Only Kaletra study. Jimenez Diaz Foundation.
« Reply #1 on: February 27, 2007, 11:58:03 AM »
Wow. could monotherapy using Kaletra be recommended in the US soon?
Infected: April 2005
12/6/06 - Diagnosed HIV positive
12/19/06 - CD4 = 240  22% VL = 26,300
1/4/07 - CD4 = 200 16% VL = ?
2/9/07 = Started Kaletra/Truvada
3/13/07 = CD4 = 386 22% VL ?

Offline newt

  • Member
  • Posts: 3,885
  • the one and original newt
Re: OK= Only Kaletra study. Jimenez Diaz Foundation.
« Reply #2 on: February 27, 2007, 12:17:27 PM »
Snazzy press release, not good enough reading of the science, the risk of virological failure is significantly higher on monotherapy as is the risk of resistance under some circumstances.  No study to date has enough power to give a general endorsement of the principle of Kaltra monotherapy or the conditions when it is a good/bad idea. Approach, but with caution.

Resistance implications of monotherapy with lopinavir/r (Kaletra)

Lopinavir monotherapy: less potent than triple therapy with higher risk of resistance

- matt
"The object is to be a well patient, not a good patient"

Offline jack

  • Member
  • Posts: 1,578
  • fomerly the loser known as Jake
Re: OK= Only Kaletra study. Jimenez Diaz Foundation.
« Reply #3 on: February 27, 2007, 12:42:09 PM »
I was in a Kaletra only study, because it was the only drug I was not resistant to, for three months. Didn't work for me,but the people working the study said results were pretty good for most. I have no idea what that means.

Offline blondbeauty

  • Member
  • Posts: 1,784
Re: OK= Only Kaletra study. Jimenez Diaz Foundation.
« Reply #4 on: February 27, 2007, 01:41:24 PM »
I would not change my triple drug combo for kaletra only (and I would also try to avoid PI for as long as possible) but it is an approach that might be acceptable for limited resource countries. This study is mainly focused to use Only Kaletra in Africa. Unfair...but who says life is fair?
The only member in these forums approved by WINBA: World International Nail and Beauty Association.
Epstein Barr +; CMV +; Toxoplasmosis +; HIV-1 +.
Counts when starting treatment:
V.L.:80.200 copies. CD4: 25%=503
Started Sustiva-Truvada 14/August/2006
Last V.L.count (Oct 2013): Undetectable
Last CD4 count (OCT 2013): 52%= 933

Offline Ihavehope

  • Member
  • Posts: 1,366
  • Yes, I'm a cry baby, AND WHAT?
Re: OK= Only Kaletra study. Jimenez Diaz Foundation.
« Reply #5 on: February 27, 2007, 02:44:11 PM »
HIV-positive patients who have suppressed their HIV viral load to undetectable levels for at least six months using traditional potent HIV therapy can safely and effectively switch to Kaletra (lopinavir/ritonavir) monotherapy and maintain undetectable viral load in the longer term, according to interim results from the KalMo study presented to the Sixteenth International AIDS Conference in Toronto on Tuesday August 15th. The study randomised patients who had achieved an undetectable viral load, and had no previous virological failure, to either continue with their multi-drug therapy or to switch to Kaletra monotherapy. After 48 weeks patients in both arms of the study had similar outcomes and, importantly, those taking Kaletra monotherapy did not have a higher risk of experiencing virological failure.

Although antiretroviral therapy can mean a longer and healthier life, it is expensive and can cause long-term side-effects. There is therefore interest in developing simplified anti-HIV treatment regimens that involve exposure to fewer antiretroviral drugs. A possible candidate for this treatment approach is the boosted protease inhibitor Kaletra as it is potent and has a high genetic barrier against the emergence of drug-resistant HIV.

The KalMo study is a 96-week open-label, randomised study that includes HIV-positive individuals who achieved a viral load below 80 copies/ml using conventional multi-drug anti-HIV treatment and have no previous virological failure. The study is being carried out at two centres in Brazil. The study recruited patients with CD4 cell counts above 200 cells/mm3 who had achieved viral load suppression on triple combination therapy for at least six months.

Participants were randomised to either continue with multi-drug therapy or to switch to Kaletra monotherapy. Interim data results based on 48-week data were presented to the Toronto conference.

A total of 60 patients were enrolled to the study, with patients in each arm being comparable at baseline. Only one patient was taking Kaletra prior to randomisation. Nineteen patients who were randomised to Kaletra had been taking an non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen previously. Participants had high CD4 cell counts (552 cells/mm3 in the Kaletra arm, 514 in the continued multi-drug arm), and had been taking antiretroviral therapy for approximately three and a half years.

At week 48, by intent-to-treat, non-completer equals failure analysis, 86% (26/30) of patients in the monotherapy arm had a viral load below 80 copies/ml compared to 83% (25/30) in the multi-drug treatment arm. This difference was not statistically significant. There was one virological failure (defined as a rebound of viral load above 1000 copies/ml) in each arm. The individual with virological failure in the monotherapy arm subsequently had their viral load re-suppressed to below 80 copies/ml after their therapy was intensified by the addition of 3TC (lamivudine, Epivir) and tenofovir (Viread). No resistance mutations were detected in either patient. A second patient in the Kaletra arm experienced a viral load blip above 80 copies/ml, but the patient's viral subsequently fell back below 80 copies without any change in treatment.

There were no significant differences at week 48 between the two arms with regard to CD4 cell count, blood lipids, and body shape change. No serious laboratory abnormalities were observed in either arm of the study. However, one patient in the monotherapy arm withdrew from the study because of diarrhoea (a recognised side-effect of Kaletra), and two individuals in the multi-drug arm changed therapy because of side-effects. Sixty-six per cent of patients in the Kaletra arm reported mild to moderate diarrhoea compared to 16% in the continued multi-drug arm. Five treatment modifications took place in the continued HAART arm due to nucleoside analogue toxicities such as peripheral neuropathy.

“Switching from various triple antiretroviral regimens to lopinavir/ritonavir monotherapy in patients who were virologically suppressed and without a history of previous virologic failure, was effective, safe and well tolerated through 48 weeks”, conclude the investigators.

Reference

Nunes EP et al. 48-week efficacy and safety results of simplification to single agent lopinavir/ritonavir regimen in patients suppressed below 80 copies/ml on HAART - the KalMo study. Sixteenth International AIDS Conference, Toronto, abstract TuAb0103, 2006.
Infected: April 2005
12/6/06 - Diagnosed HIV positive
12/19/06 - CD4 = 240  22% VL = 26,300
1/4/07 - CD4 = 200 16% VL = ?
2/9/07 = Started Kaletra/Truvada
3/13/07 = CD4 = 386 22% VL ?

Offline jack

  • Member
  • Posts: 1,578
  • fomerly the loser known as Jake
Re: OK= Only Kaletra study. Jimenez Diaz Foundation.
« Reply #6 on: February 27, 2007, 05:39:55 PM »
there are Kaletra only trials in US. I was in one. Now, I maybe it was just for people with resistance issues, I forget, I have been in so many of these things.

Offline koi1

  • Member
  • Posts: 713
Re: OK= Only Kaletra study. Jimenez Diaz Foundation.
« Reply #7 on: February 27, 2007, 09:18:38 PM »
I think the stress and anxiety of being on monotherapy would screw my numbers up sooner than the monotherapy would.

rob
diagnosed on 11/20/06 viral load 23,000  cd4 97    8%
01/04/07 six weeks after diagnosis vl 53,000 cd4 cd4 70    6%
Began sustiva truvada 01/04/07
newest labs  drawn on 01/15/07  vl 1,100    cd4 119    7%
Drawn 02/10/07
cd4=160 viral load= 131 percentage= 8%
New labs 3/10/07 (two months on sustiva truvada
cd4 count 292  percentage 14 viral load undetectable

 


Terms of Membership for these forums
 

© 2014 Smart + Strong. All Rights Reserved.   terms of use and your privacy
Smart + Strong® is a registered trademark of CDM Publishing, LLC.