Drugs / Kaletra
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Kaletra | — | 2001-03-19 | europa.eu ↗ |
| Approved | US (FDA) | KALETRA | — | 2000-09-15 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00723775 | Jul → Nov 2008 | HIV infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00032669 | Mar 2002 → Apr 2006 | HIV infectious disease | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02369406 | May 2015 → Nov 2020 overdue | AIDS | Harvard School of Public Health (HSPH) | Active not recruiting | No outcome recorded |
| Phase 44 trials · 1 missed | ||||||
| Phase 4 | NCT01045369 | Jan 2010 → Apr 2011 | HIV infectious disease | Therapeutic Concepts | Completed | No outcome recorded |
| Phase 4 | NCT00700115 | Jun 2008 → Jan 2011 | HIV infectious disease | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT00385645 | May 2006 → Aug 2009 | HIV infectious disease | Hospital Clinic of Barcelona | Completed | Missed primary |
| Phase 4 | NCT00145795 | Apr 2004 → Jun 2009 | HIV infectious disease | University of Chicago | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00247143 | Oct 2005 → ? | AIDS | Lampiris, Harry W., M.D. | Unknown | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT02631473 Comparator | Nov 2015 → Nov 2017 | HIV infectious disease | St Stephens Aids Trust | Suspended | No outcome recorded Stop: Business |
| Phase 2 | NCT00102778 Background | Dec 2004 → Sep 2007 | HIV infectious disease | ViiV Healthcare | Terminated | No outcome recorded |
| Phase 2 | NCT00052117 Background | Jan 2003 → May 2005 | HIV infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT01234116 Comparator | Feb 2011 → May 2013 | HIV infectious disease | Henry Ford Health System | Completed | No outcome recorded |
| Phase 4 | NCT00979706 Comparator | Mar 2005 → Nov 2014 | HIV infectious disease | Juan A. Arnaiz | Completed | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-02-27 | AbbVie | AbbVie Statement on Coronavirus and lopinavir/ritonavir abbvie.com ↗ |
| 2017-07-25 | GlaxoSmithKline | ViiV Healthcare announces superior efficacy of dolutegravir versus lopinavir/ritonavir in second-line HIV treatment in resource-limited settings gsk.com ↗ |
| 2006-08-17 | Vertex Pharmaceuticals Incorporated | Head-to-Head Study Comparing LEXIVA(R) (fosamprenavir calcium) to Kaletra Presented at IAC 2006 and Published in The Lancet vrtx.com ↗ |
| 2006-05-16 | Vertex Pharmaceuticals Incorporated | GlaxoSmithKline and Vertex Pharmaceuticals Announce Preliminary 48-Week Results from Head-to-Head Clinical Study of HIV Protease Inhibitors Lexiva (Telzir) and Kaletra in Treatment-naive Patients with HIV vrtx.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Kaletra | “It may include one or two nucleoside reverse transcriptase inhibitors, such as zidovudine, didanosine, lamuvidine, zalcitabine, stavudine), a non- nucleoside reverse...” NCT00032669 ↗13“The purpose of this study is to see if using a combination of other drug classes, like the ones that Kaletra® and Intelence™ belong to, can still help reduce the amount of HIV...” NCT01045369 ↗ “Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day.” NCT01234116 ↗ “Patients assigned to this arm will receive Trizivir and kaletra.” NCT00979706 ↗ |
| Known as | lopinavir/ritonavir | “Kaletra (lopinavir/ritonavir) may be of benefit to patients with poor immune responses to HAART despite viral suppression.” NCT00145795 ↗ |
| Action | Inhibit | “We also are interested in knowing if this agent improves immune response by affecting cluster of differentiation 4 (CD4) + T cell death (apoptosis) or by further inhibiting...” NCT00145795 ↗ |
| Route | Oral | “taken by mouth” NCT00700115 ↗ |