Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS

Completed

• Conditions: Acquired Immunodeficiency Syndrome
• Interventions: Drug: Nevirapine (Viramune®)

• Registration Number: NCT02191215
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The aim of the Post Marketing Study (PMS) is to evaluate the efficacy and safety profile of nevirapine in the management of the HIV/AIDS in an open environment.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2004-05
• Status Verified: 2014-07
• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-15
• Last Update Submitted: 2014-07-15
• Study First Posted: 2014-07-16
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

Inclusion Criteria

• diagnosis of HIV/AIDS, no age limits
• patients could be naïve to treatment or pretreated with other antiretroviral agents

Exclusion Criteria

• Patients with known hypersensitivity to nevirapine or any other component of the product

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nevirapine (Viramune®)	Nevirapine (Viramune®)	-

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse event	up to 90 days
Change in body weight	Baseline, up to 90 days
Change in cluster of differentiation 4 (CD4) cell count	Baseline, up to 90 days
Change in viral load (HIV RNA)	Baseline, up to 90 days