Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: July 15, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
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.

Condition Intervention
Acquired Immunodeficiency Syndrome
Drug: Nevirapine (Viramune®)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change in body weight [ Time Frame: Baseline, up to 90 days ] [ Designated as safety issue: No ]
  • Change in cluster of differentiation 4 (CD4) cell count [ Time Frame: Baseline, up to 90 days ] [ Designated as safety issue: No ]
  • Change in viral load (HIV RNA) [ Time Frame: Baseline, up to 90 days ] [ Designated as safety issue: No ]
  • Number of patients with adverse event [ Time Frame: up to 90 days ] [ Designated as safety issue: No ]

Enrollment: 442
Study Start Date: June 2003
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Nevirapine (Viramune®) Drug: Nevirapine (Viramune®)


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mexican patients infected by HIV/AIDS

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim Identifier: NCT02191215     History of Changes
Other Study ID Numbers: 1100.1457 
Study First Received: July 15, 2014
Last Updated: July 15, 2014
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors processed this record on May 24, 2016