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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

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


Condition or disease Intervention/treatment Phase
HIV Infections Other: Nevirapine plus lamivudine Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Actual Study Start Date : December 23, 2016
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223402


Locations
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Switzerland
Kantonsspital St. Gallen
St. Gallen, SG, Switzerland, 9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Investigators
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Principal Investigator: Pietro L Vernazza, MD KSSG

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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
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: not planned

Additional relevant MeSH terms:
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Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lamivudine
Nevirapine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers