Acquired Immunodeficiency Syndrome Clinical Trial
Official title:
Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS
NCT number | NCT02191215 |
Other study ID # | 1100.1457 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | July 15, 2014 |
Last updated | July 15, 2014 |
Start date | June 2003 |
Verified date | July 2014 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | Mexico: Ministry of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 442 |
Est. completion date | |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
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 |
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