Clinical and Therapeutic Evaluation of the Infection by H... | NCT02191215

Studies
Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS

NCT02191215

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 16, 2014Estimated

Enrollment

442Actual

Phase

Not provided

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Nevirapine (Viramune®)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

May 2004Actual

Completion Date

Not provided

First Submitted Date

Jul 15, 2014

First Submission Date that Met QC Criteria

Jul 15, 2014

First Posted Date

Jul 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2014

Last Update Posted Date

Jul 16, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

442Actual

Label	Type	Description	Intervention Names
Nevirapine (Viramune®)			Drug: Nevirapine (Viramune®)

Name	Type	Description	Arm Group Labels	Other Names
Nevirapine (Viramune®)	Drug		Nevirapine (Viramune®)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Mexican patients infected by HIV/AIDS

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019829	Nevirapine

Ancestor Terms

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided