Navigation Links
New Phase 3 Study in Treatment-Naive Adults with HIV Evaluates Efficacy and Safety of Once-Daily PREZISTA(TM)/ritonavir vs. KALETRA(R) as Part of HIV Combination Therapy
Date:9/18/2007

ek primary analysis from ARTEMIS will be submitted to the FDA later this year as part of the post-marketing commitment for PREZISTA.

PREZISTA, co-administered with 100 mg ritonavir and with other antiretroviral agents, is currently indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.

This indication is based on week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled trials of PREZISTA/r in combination with other antiretroviral drugs. Both studies were conducted in clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

The following points should be considered when initiating therapy with PREZISTA/r:

-- Treatment history and, when available, genotypic or phenotypic testing

should guide the use of PREZISTA/r.

-- The use of other active agents with PREZISTA/r is associated with a

greater likelihood of treatment response.

-- The risks and benefits of PREZISTA/r have not been established in

treatment-naive adult patients or pediatric patients.

PREZISTA received accelerated approval in June 2006 based on the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2) Phase 2b studies. As part of the post-marketing commitment, 48-week data from ongoing Phase 3 studies, including ARTEMIS, and 96-week data from POWER 1, 2, and 3 will be required before the FDA can consider traditional approval for PREZISTA.

About the ARTEMIS study

ARTEMIS is an international ongoing, randomized, open-label Phase 3 trial in which 689 treatment-naive adult patients were treated. The participants enrolled in the study had not previously received treatment w
'/>"/>

SOURCE Tibotec Therapeutics
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
2. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
3. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
4. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
5. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
6. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
7. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
8. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
9. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
10. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
11. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2015)... DUBLIN , Aug. 28, 2015 ... has announced the addition of the "Investigation ... report to their offering. Developed by ... of Novolog) is an important drug for the ... aspart, as a fast- acting insulin analog, starts ...
(Date:8/28/2015)... 2015  IP Shakti, LLC, today announced that it has ... Logo - http://photos.prnewswire.com/prnh/20150827/261551LOGO ... corporate identity signifies our transformation into a company focused on ... for patent claim validity." ... AIA Shield™ platform, the Company commenced a corporate re-branding initiative ...
(Date:8/28/2015)... and PITTSBURGH , ... MYL ) today announced that its shareholders have ... (NYSE: PRGO ; TASE) and the related ... at an extraordinary general meeting of shareholders held ... votes cast at the extraordinary general meeting. In ...
Breaking Medicine Technology:China Insulin Aspart Market Report 2010-2019 - Developed by Novo Nordisk 2IP Shakti, LLC Changes Company Name to Prediqtus, LLC 2Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 2Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 3Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 4Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 5Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 6Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 7Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 8Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 9
... Heska Corporation (NASDAQ: HSKA ), a provider ... , today announced that Robert Grieve, Heska,s Chairman and CEO, ... 2011 at 10:30 a.m. PT / 1:30 p.m. ET.  The ... Hotel in Los Angeles. (Logo: http://photos.prnewswire.com/prnh/20000622/HESKALOGO ) ...
... Md., Sept. 13, 2011 Sodexo, Inc., a leader ... with Healthsense, Inc.  As a part of the agreement, ... existing senior living client communities – expanding Sodexo,s current ... Life for all of the people and communities they ...
Cached Medicine Technology:Heska to Present at LD MICRO Invitational on September 22, 2011 2Sodexo Partners with Healthsense to Offer Seniors Technology-Enabled Solutions that Improve Quality of Daily Life 2Sodexo Partners with Healthsense to Offer Seniors Technology-Enabled Solutions that Improve Quality of Daily Life 3
(Date:8/30/2015)... ... August 31, 2015 , ... Negotiating an FDA Import Hold Crisis:, Strategies ... p.m. EDT, http://www.fdanews.com/importholdcrisis , US authorities are holding imports more than ever ... India. , With alerts on an uptick and a new final rule, having a ...
(Date:8/30/2015)... ... August 31, 2015 , ... ChopChop Kids, the nonprofit publisher ... recently elected two new officers to serve on the organization’s Board of Directors ... and teaching kids to cook real food with their families and help continue ...
(Date:8/30/2015)... ... August 30, 2015 , ... ... to announce that Partner Daniel M. Kotin was recently elected to membership in ... constitutes the highest degree of peer recognition and outstanding professionalism. , ABOTA ...
(Date:8/30/2015)... ... August 30, 2015 , ... Lizzie’s Lice Pickers , a company ... The company is currently offering lice head checks for just $10, which is a ... a 10% discount on their lice treatment products. “With kids returning to school, it ...
(Date:8/30/2015)... ... August 30, 2015 , ... InHealth Media ( http://www.inhealthmedia.com ) ... Communications Director for InHealth Media. Mr. Spector comes with a wide array ... doing on-air television, producing shows, on air-radio and media relations. , Brian ...
Breaking Medicine News(10 mins):Health News:FDAnews Announces — Negotiating an FDA Import Hold Crisis: Strategies for Challenging FDA Findings Webinar, Sept. 22, 2015 2Health News:FDAnews Announces — Negotiating an FDA Import Hold Crisis: Strategies for Challenging FDA Findings Webinar, Sept. 22, 2015 3Health News:ChopChop Kids Appoints New Chair and Vice-Chair to Board of Directors 2Health News:ChopChop Kids Appoints New Chair and Vice-Chair to Board of Directors 3Health News:Chicago Personal Injury Lawyer Daniel M. Kotin Elected to the American Board of Trial Advocates 2Health News:Chicago Personal Injury Lawyer Daniel M. Kotin Elected to the American Board of Trial Advocates 3Health News:Lizzie’s Lice Pickers Announces Back to School Head Check Special and Discounted Lice Treatment Products 2Health News:InHealth Media Appoints New Global Communications Director 2
... http://www.minuteclinic.com ), the pioneer and largest provider ... announced that it has become a,participating provider ... national provider of individual medical,small group and ... a MinuteClinic health care center, members enrolled ...
... Ltd., the biomedical,research group and developer of the ... Exempla Healthcare has contracted to utilize QDS,internet Quality ... QDS automates the gap between donor registration ... utilizes audio-visual touch screen computer,assisted donor self interviewing ...
... war on asthma symptom control could be a psychological one, ... and Dads leeriness towards their childrens asthma medications simply ... that outweigh the benefits might explain to some extent ... the wheezing, coughing and trouble-breathing disease do not take their ...
... by UT Southwestern Medical Center researchers has found that overweight ... high risk for iron deficiency. , Based on data ... that 20 percent of overweight toddlers were iron-deficient, compared to ... 7 percent of normal-weight toddlers. , The study, appearing ...
... weeks press release: , , Renal function and coronary ... mice by mesenchymal stem cells overexpressing angiopoietin 1, , , ... the links below to take your readers straight to ... ARTICLES WILL BE PUBLISHED ONLINE: , , Renal function and ...
... 28 at 11 a.m. in Nashville, NASHVILLE, ... leaders from Tennessee will hold a press conference ... granting the U.S.,Food and Drug Administration (FDA) authority ... entire Tennessee Congressional Delegation,particularly U.S. Representatives Bart Gordon ...
Cached Medicine News:Health News:MinuteClinic Becomes Participating Provider with Assurant Health 2Health News:MinuteClinic Becomes Participating Provider with Assurant Health 3Health News:Exempla Healthcare Contracts For Talisman's Quality Donor System 2Health News:Parents' perceptions can hamper kids' asthma care, study finds 2Health News:Parents' perceptions can hamper kids' asthma care, study finds 3Health News:Overweight toddlers and those not in day care at risk for iron deficiency 2Health News:Overweight toddlers and those not in day care at risk for iron deficiency 3Health News:Renal function and heart disease, and more 2Health News:Tennessee Faith Leaders Call on Reps. Gordon & Blackburn to Co-sponsor Legislation to Protect Kids from Tobacco 2
... Single Use linear stapler with LACTOMER™ ... Suture™ PREMIUM POLY CS™-57 disposable surgical ... of a temporary opening, such as ... section, or when transecting muscle tissue, ...
... Units With Titanium Staples for ... (Single Use Reloadable Stapler with ... Suture™ PREMIUM MULTIFIRE TA™ stapler ... pediatric and thoracic surgical procedures ...
... Single Use Loading Units for ... (Single Use Reloadable Staplers with ... Suture™ TA™ Reloadable staplers has ... and thoracic surgical procedures for ...
... linear stapler for resection, transection and anastomosis ... MULTIFIRE GIA™ 60 and 80 single use ... 80 single use loading units and the ... use surgical stapler with MULTIFIRE SGIA™ 60 ...
Medicine Products: