NCT02191215

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
442

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
Last Updated

July 16, 2014

Status Verified

July 1, 2014

Enrollment Period

11 months

First QC Date

July 15, 2014

Last Update Submit

July 15, 2014

Conditions

Acquired Immunodeficiency Syndrome

Outcome Measures

Primary Outcomes (4)

  • Change in body weight

    Baseline, up to 90 days

  • Change in cluster of differentiation 4 (CD4) cell count

    Baseline, up to 90 days

  • Change in viral load (HIV RNA)

    Baseline, up to 90 days

  • Number of patients with adverse event

    up to 90 days

Study Arms (1)

Nevirapine (Viramune®)

Drug: Nevirapine (Viramune®)

Interventions

Nevirapine (Viramune®)DRUG
Nevirapine (Viramune®)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mexican patients infected by HIV/AIDS

You may qualify if:

  • diagnosis of HIV/AIDS, no age limits
  • patients could be naïve to treatment or pretreated with other antiretroviral agents

You may not qualify if:

  • Patients with known hypersensitivity to nevirapine or any other component of the product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 16, 2014

Study Start

June 1, 2003

Primary Completion

May 1, 2004

Last Updated

July 16, 2014

Record last verified: 2014-07