Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02191215
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : July 16, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Acquired Immunodeficiency Syndrome Drug: Nevirapine (Viramune®)

Study Type : Observational
Actual Enrollment : 442 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS
Study Start Date : June 2003
Actual Primary Completion Date : May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Nevirapine

Group/Cohort Intervention/treatment
Nevirapine (Viramune®) Drug: Nevirapine (Viramune®)

Primary Outcome Measures :
  1. Change in body weight [ Time Frame: Baseline, up to 90 days ]
  2. Change in cluster of differentiation 4 (CD4) cell count [ Time Frame: Baseline, up to 90 days ]
  3. Change in viral load (HIV RNA) [ Time Frame: Baseline, up to 90 days ]
  4. Number of patients with adverse event [ Time Frame: up to 90 days ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Responsible Party: Boehringer Ingelheim Identifier: NCT02191215     History of Changes
Other Study ID Numbers: 1100.1457
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

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
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers