Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS

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.

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Key information

Conditions

Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nevirapine (VIRAMUNE®)

Drug

Primary outcomes

Change in body weight

Time frame: Baseline, up to 90 days
Change in cluster of differentiation 4 (CD4) cell count

Time frame: Baseline, up to 90 days
Change in viral load (HIV RNA)

Time frame: Baseline, up to 90 days
Number of patients with adverse event

Time frame: up to 90 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start: 2003
Primary completion: 2004
First posted: Jul 16, 2014
Registry last updated: Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed