Drugs / Abacavir/Lamivudine
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT00740064 | May 2008 → Aug 2009 | HIV infectious disease | Denver Infectious Disease Consultants, PLLC | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2016-07-18 | GlaxoSmithKline | Results ARIA study shows superior efficacy of Triumeq® for treatment-naïve women living with HIV gsk.com ↗
ViiV Healthcare today presented 48-week data from the phase IIIb, open-label, international, multi-centre ARIA study which showed superior efficacy for Triumeq® (dolutegravir/abacavir/lamivudine) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 495 treatment-naïve women living with HIV. |
| 2015-09-23 | GlaxoSmithKline | Results New Phase IIIb/IV data show switching to once-daily Triumeq® maintains HIV viral suppression gsk.com ↗
Furthermore, statistically, the treatment satisfaction score improved significantly more for those patients switching to once-daily abacavir/dolutegravir/lamivudine from their established regimen, as assessed by the HIV Treatment Satisfaction Questionnaire (adjusted difference 2.4, 95% CI: 1.3, 3.5; p<0.001). |
| 2014-09-03 | GlaxoSmithKline | Regulatory ViiV Healthcare receives EU marketing authorisation for Triumeq® (dolutegravir/abacavir/lamivudine), a new once-daily single-pill regimen for the treatment of HIV gsk.com ↗
We are delighted with today’s approval that offers people living with HIV in Europe the first single-pill regimen containing dolutegravir. |
| 2014-08-22 | GlaxoSmithKline | Regulatory ViiV Healthcare receives FDA approval for Triumeq® (abacavir, dolutegravir and lamivudine), a new single-pill regimen for the treatment of HIV-1 infection gsk.com ↗
ViiV Healthcare announced today that the US Food and Drug Administration (FDA) has approved Triumeq® (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection. |
| 2014-06-27 | GlaxoSmithKline | Regulatory Triumeq® (dolutegravir/abacavir/lamivudine) single-tablet regimen receives positive CHMP opinion in Europe for the treatment of HIV gsk.com ↗
the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Triumeq® (dolutegravir/abacavir/lamivudine) |
| 2013-10-22 | GlaxoSmithKline | Regulatory ViiV Healthcare announces US regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV gsk.com ↗
ViiV Healthcare today announced the submission of a regulatory application in the United States for its investigational single-tablet regimen (STR) combining dolutegravir, abacavir and lamivudine for the treatment of people living with HIV-1. |
| 2012-07-11 | GlaxoSmithKline | Results Shionogi-ViiV Healthcare announces positive initial data from phase III study of dolutegravir-based regimen vs Atripla in HIV gsk.com ↗
The study demonstrated superiority of the dolutegravir-based regimen compared to the single tablet regimen Atripla®. |
All press releases naming this drug 7 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Abacavir/Lamivudine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00740064 ↗ |