Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02191215
First received: July 15, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

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®)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Mexican patients infected by HIV/AIDS

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov 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:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Nevirapine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 18, 2014