Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS

Acquired Immunodeficiency Syndrome Clinical Trial

Official title:

Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191215
• Other study ID #: 1100.1457
• Status: Completed
• Phase: N/A
• First received: July 15, 2014
• Last updated: July 15, 2014
• Start date: June 2003

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Nevirapine (Viramune®)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight		Baseline, up to 90 days	No
Primary	Change in cluster of differentiation 4 (CD4) cell count		Baseline, up to 90 days	No
Primary	Change in viral load (HIV RNA)		Baseline, up to 90 days	No
Primary	Number of patients with adverse event		up to 90 days	No

External Links

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