Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Cantonal Hospital of St. Gallen


Information provided by (Responsible Party)
pietro vernazza, Cantonal Hospital of St. Gallen

ClinicalTrials.gov Identifier
NCT03223402

First received: December 15, 2016
Last updated: July 16, 2018
Last Verified: July 2018
History of Changes
Purpose

Purpose

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

Condition Intervention
HIV Infections

Other : Nevirapine plus lamivudine

Study Type: Interventional
Study Design: 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
Official Title: NEVIRAPINE Plus LAMIVUDINE (3TC) for HIV Maintenance Therapy - A Single Center Pilot Study

Further study details as provided by pietro vernazza, Cantonal Hospital of St. Gallen:

Primary Outcome Measures

  • 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.

Enrollment: 20
Study Start Date: December 23, 2016
Study Completion Date: May 31, 2018
Primary Completion Date: May 15, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: nevirapine plus lamivudine
patients from one Center switching from a Nevirapine based Regimen on Nevirapine + 3TC
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.

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

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: NCT03223402

Locations

Switzerland
Kantonsspital St. Gallen
St. Gallen, SG, Switzerland, 9007

Sponsors and Collaborators

Cantonal Hospital of St. Gallen

Investigators

Principal Investigator: Pietro L Vernazza, MD KSSG
More Information

More Information


Responsible Party: pietro vernazza, Chief Div. Infectious Diseases, Cantonal Hospital of St. Gallen  
ClinicalTrials.gov Identifier: NCT03223402   History of Changes  
Other Study ID Numbers: BASEC Nr. 2016-01963  
Study First Received: December 15, 2016  
Last Updated: July 16, 2018  
Individual Participant Data    
Plan to Share IPD: No  

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lamivudine
Nevirapine

ClinicalTrials.gov processed this data on September 16, 2019
This information is provided by ClinicalTrials.gov.