NCT03223402|Completed
Nevirapine + 3TC Based Maintenance Therapy for HIV Infection
NVP+3TC
NEVIRAPINE Plus LAMIVUDINE (3TC) for HIV Maintenance Therapy - A Single Center Pilot Study
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NVP+3TC
NEVIRAPINE Plus LAMIVUDINE (3TC) for HIV Maintenance Therapy - A Single Center Pilot Study
Sponsor study identifier
interventional
20
1 country
1
Study Start
December 23, 2016
Actual (reported)Primary Completion
May 15, 2018
Actual (reported)Study Completion
May 31, 2018
Actual (reported)Type of study: Investigator initiated clinical study Study design: One arm, open label, pilot study (n=10) Research question Is treatment with Nevirapine + 3TC sufficient for HIV maintenance Risk Category B (no investigational drugs, non standard Tx) Therapies with 2 drugs are often done in HIV-maintenance. This is a systematical evaluation of such a two drug trial. Rescue therapy is well defined within the protocol. Centers (n) St. Gallen only Participants 10 HIV Patients already on nevirapine + 2 non-nuke RT-Inhibitors Study duration 24 weeks primary observation period after study termination, patients may opt to continue on the bi-therapy. Clinical follow up will then continue Sponsor/Investigator Pietro Vernazza, Kantonsspital St. Gallen Principal investigator Pietro Vernazza, MD. Kantonsspital St. Gallen Co-Investigators Patrick Schmid, MD, Matthias Hoffmann, MD Financial source None (Pilot Study) If study demonstrates good results, an SNF grant proposal will be submitted
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 15, 2016
Actual (reported)December 23, 2016
Actual (reported)July 21, 2017
Actual (reported)May 15, 2018
Actual (reported)May 31, 2018
Actual (reported)Treatment failure defined as HIV-RNA > 100 cp/ml
Patients reaching a viral load measurement \>100cp /ml (confirmed) within the first 24 weeks of therapy with monthly HIV-RNA testing.
24 weeks
patients from one Center switching from a Nevirapine based Regimen on Nevirapine + 3TC
In this Pilot study, the efficacy of a bi-therapy consisting of NVP+3TC instead of NVP+2NRTI should be evaluated before a large multicenter study evaluating this combination is started.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Nevirapine plus lamivudine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordKantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Pietro L Vernazza, MD
KSSG
20 participants (actual enrollment reported by the registry).
First Submitted
December 15, 2016
First Posted
July 21, 2017
Study Start
December 23, 2016
Piloting At-birth Point of Care HIV Testing Strategies in Kenya
Contact the study team to confirm eligibility.
Primary Completion
May 15, 2018
Actual (reported)Study Completion
May 31, 2018
Actual (reported)Last Updated
July 18, 2018
Record last verified: 2018-07
not planned
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Source: ClinicalTrials.gov.
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