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Author Topic: GEMINI trial - study, dual therapy with dolutegravir plus lamivudine  (Read 4271 times)

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Online Jim Allen

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I thought this was an interesting read on dual therapy.

Personally I would not mind being part of this study if the chance did come along. Taking just the dolutegravir plus lamivudine versus the standard regimen of dolutegravir plus tenofovir/emtricitabine being offered.

http://www.aidsmap.com/page/3074283/
"We need to wait and see," Dr Cahn cautioned. "Donít do this at home until we have the results."

"In this pilot, proof of concept study, dual therapy with dolutegravir plus lamivudine induced rapid virologic suppression with a favourable safety/tolerability profile in HIV-1 infected, treatment-naive individuals," the researchers concluded. "If confirmed in a well powered randomized clinical trial, this two-drug regimen might be considered as a simple, potent, well tolerated and potentially cheap strategy for HIV treatment initiation."

Dr Cahn said more data from larger trials is needed to determine if dual therapy is a safe and effective strategy.


Next: https://clinicaltrials.gov/show/NCT02831673
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Offline gorka

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Re: GEMINI trial - study, dual therapy with dolutegravir plus lamivudine
« Reply #1 on: July 26, 2016, 11:41:56 am »
how does one find locations participating?   I only see the following

Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02831673

Online Jim Allen

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Re: GEMINI trial - study, dual therapy with dolutegravir plus lamivudine
« Reply #2 on: July 26, 2016, 12:51:01 pm »
Well under contacts it has: (Don't hold your breath about joining)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02831673

Contacts

Contact: US GSK Clinical Trials Call Center   877-379-3718   GSKClinicalSupportHD@gsk.com   
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Offline awakening

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Re: GEMINI trial - study, dual therapy with dolutegravir plus lamivudine
« Reply #3 on: July 26, 2016, 02:20:40 pm »
Thanks for posting this Jim.

The study is only for ARV therapy naive patients (less than 10 days on ART after testing positive). The combo being compared is Triumeq minus the Abacavir, the one ingredient associated with potentially more side effects than the other two.
~~~~
[month/date/year]
3/1/16: Tested neg (Oral swab)
6/17/16: Diagnosed poz (finger prick), confirmed w/Multispot assay
6/17/16: VL 22,900, CD4 - 524 cells/uL (30%)
7/2/16: Started Triumeq (DTG+ABC+3TC)
8/1/16: VL 30
10/4/16: VL <20, CD4 - 630 (31%)
1/4/17: VL 90
2/7/17: Undetected
4/17/17: Undetected, CD4 - 695 (33%)
7/20/17: VL 75
8/21/17: VL <20
11/27/17: VL<20
3/26/18: VL<20, CD4 - 701 (36%)
5/14/18: Switch to Juluca (DTG+RPV)
6/11/18: VL<20
7/25/18: Undetected, CD4 - 632 (38%)
1/22/19: VL<20

Online Jim Allen

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Re: GEMINI trial - study, dual therapy with dolutegravir plus lamivudine
« Reply #4 on: July 26, 2016, 02:48:34 pm »
Hence I said to gorka, don't hold your breath.  ;)

Still if it was ever offered to a wider scope of people I would not mind trying, sounds very interesting.

Jim
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Offline connor

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Re: GEMINI trial - study, dual therapy with dolutegravir plus lamivudine
« Reply #5 on: September 15, 2016, 12:50:02 am »
I've been on dual therapy with Dolutegravir and Lumivudine since around Christmas 2015. I had hypersensitivity to Abacavir component of Triumeq within a week of starting Triumeq. I was tested okay to go on Abacavir bit I am one of the few people who became hypersensitive. It was a horrible experience. My consultant doctor decided to take Abacavir out of the equation and so I've been left on Dolutegravir and Lumivudine with good results. I've no side effects compared to previous regimes which is why I changed meds so often as you can see in my signature underneath. I have with or without food.
« Last Edit: September 15, 2016, 12:55:31 am by connor »
04 Mar 2014 Negative test results
14 May 2014 CD4 530 VL 10,000 TDF+FTC+RAL+DRV+RTV (started meds during seroconversion. HIV-1 subtype B)
28 May 2014 CD4 630 VL 66,182
17 Jun 2014 CD4 704 VL UD TDF+FTC+RAL
26 Aug 2014 CD4 646 VL UD
28 Oct 2014 CD4 797 VL UD TDF+FTC+EVG/c
12 May 2015 CD4 730 VL UD
08 Sep 2015 CD4 787 VL UD
13 Nov 2015 CD4 658 VL UD DTG+3TC+ABC (hypersensitivity ABC)
20 Nov 2015 CD4 718 VL UD TDF+FTC+RAL
21 Mar 2016 CD4 889 VL UD DTG+3TC (Dual Therapy. Gemini Study)
13 Jun 2016 CD4 1006 VL UD
29 Aug 2016 CD4 1081 VL UD
02 Dec 2016 CD4   801  VL UD
13 MAR 2017 CD4 1070 35% UD
01 JUN  2017 CD4   994 42% UD
16 NOV 2017 CD4 1168 34% UD
20 APR 2018 CD4    982 38% UD
04 OCT 2018 CD4    681 33% UD
01 APR 2019 CD4    978 35% UD

Online Jim Allen

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Re: GEMINI trial - study, dual therapy with dolutegravir plus lamivudine
« Reply #6 on: September 15, 2016, 02:25:38 am »
Sorry to hear you where hypersensitive to Abacavir, but glad to hear your treatment is working well.

Jim
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Offline vrsan

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Re: GEMINI trial - study, dual therapy with dolutegravir plus lamivudine
« Reply #7 on: September 16, 2016, 05:13:13 am »
Interesting read, thank you! As i'm already on 3TC+DTG+TDF, i hope this study will find that dual therapy works safely, and works for people already on treatment as well. I really wouldn't mind getting rid for Tenofovir DF :)

Offline terrymoore

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Re: GEMINI trial - study, dual therapy with dolutegravir plus lamivudine
« Reply #8 on: September 19, 2016, 04:01:34 am »
What would be the advantage of a Dual therapy as opposed to the triple? Why is it better to take 2 drugs and not 3?

Offline Ptrk3

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Re: GEMINI trial - study, dual therapy with dolutegravir plus lamivudine
« Reply #9 on: September 19, 2016, 05:26:06 am »
I believe that some of the advantages may be cost (elimination of one drug should, theoretically, make a retroviral cheaper, at least after a while), pill burden (i.e., the lesser chance of side effects since one drug would be eliminated), access (perhaps, more people worldwide would be able to be medicated) and pharmaceutical production (simpler way to make life-sustaining retroviral medication). 

Why take three drugs when two will do?
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Offline awakening

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Re: GEMINI trial - study, dual therapy with dolutegravir plus lamivudine
« Reply #10 on: November 03, 2016, 02:32:34 am »
Good results from recent dual-therapy studies:

https://www.poz.com/article/two-hiv-drugs-can-good-three

Quote
HIV-positive individuals who switched from a standard three-drug antiretroviral (ARV) regimen to a two-drug combination of a boosted protease inhibitor and Epivir (lamivudine) did well in a recent trial, aidsmap reports.
~~~~
[month/date/year]
3/1/16: Tested neg (Oral swab)
6/17/16: Diagnosed poz (finger prick), confirmed w/Multispot assay
6/17/16: VL 22,900, CD4 - 524 cells/uL (30%)
7/2/16: Started Triumeq (DTG+ABC+3TC)
8/1/16: VL 30
10/4/16: VL <20, CD4 - 630 (31%)
1/4/17: VL 90
2/7/17: Undetected
4/17/17: Undetected, CD4 - 695 (33%)
7/20/17: VL 75
8/21/17: VL <20
11/27/17: VL<20
3/26/18: VL<20, CD4 - 701 (36%)
5/14/18: Switch to Juluca (DTG+RPV)
6/11/18: VL<20
7/25/18: Undetected, CD4 - 632 (38%)
1/22/19: VL<20

Online Jim Allen

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Re: GEMINI trial - study, dual therapy with dolutegravir plus lamivudine
« Reply #11 on: November 03, 2016, 03:01:04 am »
Yeah, this was not bad result, very promising indeed. I still have to read in detail but it's looking good for further development/study. 

"After 48 weeks of treatment, a respective 89.5 percent and 79.7 percent of those in the dual and triple therapy arms had not failed treatment"

For the ongoing GEMINI 1 and 2 study it will be intressting to see publications once conculded at 48 weeks and than also the 148 weeks total from the study to see the long-term efficiency and the safety.

Jim


https://www.poz.com/article/viiv-begins-phase-iii-trial-twodrug-hiv-regimen
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