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Nevirapine + 3TC Based Maintenance Therapy for HIV Infection (NVP+3TC)

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ClinicalTrials.gov Identifier: NCT03223402
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
pietro vernazza, Cantonal Hospital of St. Gallen

Tracking Information
First Submitted Date  ICMJE December 15, 2016
First Posted Date  ICMJE July 21, 2017
Last Update Posted Date July 18, 2018
Actual Study Start Date  ICMJE December 23, 2016
Actual Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
Treatment failure defined as HIV-RNA > 100 cp/ml [ Time Frame: 24 weeks ]
Patients reaching a viral load measurement >100cp /ml (confirmed) within the first 24 weeks of therapy with monthly HIV-RNA testing.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03223402 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nevirapine + 3TC Based Maintenance Therapy for HIV Infection
Official Title  ICMJE NEVIRAPINE Plus LAMIVUDINE (3TC) for HIV Maintenance Therapy - A Single Center Pilot Study
Brief Summary

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

Detailed Description

This is a pilot study to evaluate the efficacy of a two drug combination for Long term HIV maintenance therapy.

The study is conducted in order to confirm the feasibility of the combination of Nevirapine and lamivudine (3TC) in patients with long term fully suppressive therapy.

Patients (n=10) with a stable (>6 months) Nevirapine based triple therapy and a full viral load suppression for at least 2 years will continue their therapy for 6 months with Nevirapine+3TC.

The primary endpoint is treatment failure defined as an HIV-RNA value >100 cp/ml, confirmed by a second measurement.

Preliminary stopping rules are defined if results indicate futility. Futility is defined as a situation, where the investigators would stop their plan to conduct a multicenter comparative trial. Futility is reached, when the study documents more than 1 failure in the first 5 patients over 24 weeks of observation or more than 2 failures in all 10 patients.

Only 10 patients will be followed in this single center pilot study.

After an amendement (April 2017) the total number of 20 patients was increased to 20. Futility was defined as more than 2 failures in 20 patients.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Pilot study, one arm. We do not evaluate a specific drug. It is an Evaluation of a combination with just two instead of three drugs for the Treatment of HIV
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE Other: Nevirapine plus lamivudine
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.
Study Arms  ICMJE Experimental: nevirapine plus lamivudine
patients from one Center switching from a Nevirapine based Regimen on Nevirapine + 3TC
Intervention: Other: Nevirapine plus lamivudine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2018)
20
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2017)
10
Actual Study Completion Date  ICMJE May 31, 2018
Actual Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV-pos, 18 years
  • Stable ART, Nevirapine based (plus 2 nukleotide-analogues), at least 6 months
  • Viral load suppression at least 24 months Prior to inclusion (<50cp/ml)

Exclusion Criteria:

  • chronic Hepatitis B necessitating tenofovir therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03223402
Other Study ID Numbers  ICMJE BASEC Nr. 2016-01963
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: not planned
Responsible Party pietro vernazza, Cantonal Hospital of St. Gallen
Study Sponsor  ICMJE Cantonal Hospital of St. Gallen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pietro L Vernazza, MD KSSG
PRS Account Cantonal Hospital of St. Gallen
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP