Nevirapine + 3TC Based Maintenance Therapy for HIV Infection

NCT ID: NCT03223402

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-23
• Study Completion Date: 2018-05-31

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.

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nevirapine plus lamivudine

patients from one Center switching from a Nevirapine based Regimen on Nevirapine + 3TC

Group Type: EXPERIMENTAL

Nevirapine plus lamivudine

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: lead

Responsible Party

pietro vernazza

Chief Div. Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pietro L Vernazza, MD

Role: PRINCIPAL_INVESTIGATOR

KSSG

Locations

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

Countries

Switzerland

Other Identifiers

BASEC Nr. 2016-01963

Identifier Type: -

Identifier Source: org_study_id