Trial intelligence / Profile preview

Prednisone for Prevention of Nevirapine-Associated Rash

NCT02184299Phase 4

Key facts

Status: Completed
Start: Apr 1999
Primary completion: Jan 2000
Sponsor: Boehringer Ingelheim
Modality: Orthosteric Ligands

Drugs: prednisone
Conditions: drug eruption

Overview

Phase 4, randomised, open-label trial of prednisone in drug eruption (2 arms), sponsored by Boehringer Ingelheim. Primary endpoint: Incidence of rash at 42 days. Started Apr 1999; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Nevirapine + Prednisone
Nevirapine with a short course of Prednisone for the first 2 weeks
Nevirapine
Nevirapine alone

Who it enrols

Patients with HIV-1 infection, CD4+ count >= 100 cells/mm3 (>= 200 if history of AIDS), and no prior NNRTI therapy.

Endpoints

Primary

Incidence of rash42 days

Secondary

Severity of rash42 days
Change in Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) count24 weeks
Number of patients with adverse events198 days
Change in Lymphocytes expressing CD4+ Surface Marker (CD4+) count24 weeks

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