Nevirapine + 3TC Based Maintenance Therapy for HIV Infection

NCT03223402 | Completed

• 1 other identifier: BASEC Nr. 2016-01963
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

nevirapine plus lamivudine

EXPERIMENTAL

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

Other: Nevirapine plus lamivudine

Interventions

Nevirapine plus lamivudine 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.

nevirapine plus lamivudine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-pos, 18 years
• Stable ART, Nevirapine based (plus 2 nukleotide-analogues), at least 6 months

You may not qualify if:

• chronic Hepatitis B necessitating tenofovir therapy

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

Study Sites (1)

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine; Lamivudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Pietro L Vernazza, MD

  KSSG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Div. Infectious Diseases

Model Details: 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

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: July 21, 2017
• Study Start: December 23, 2016
• Primary Completion: May 15, 2018
• Study Completion: May 31, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)