Observational Study in Patients With HIV Infection Type 1... | NCT02191332

Studies
Observational Study in Patients With HIV Infection Type 1 After Switching to a Viramune®-Containing Therapy Regimen

NCT02191332

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 16, 2014Estimated

Enrollment

147Actual

Phase

Not provided

Conditions

HIV Infections

Interventions

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

Dec 1999

Primary Completion Date

Nov 2001Actual

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

Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) despite switching from protease inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).

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

147Actual

Label	Type	Description	Intervention Names
Viramune			Drug: Viramune

Name	Type	Description	Arm Group Labels	Other Names
Viramune	Drug		Viramune

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in viral load (HIV-RNA)		Baseline, after 26 and 52 weeks
Change in CD4 cell count		Baseline, after 26 and 52 weeks
Change in lipid status (lipodystrophy, triglycerides, cholesterol)	verbal rating scale	Baseline, after 26 and 52 weeks
Change in glucose tolerance	verbal rating scale	Baseline, after 26 and 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Assessment of subjective well-being	verbal rating scale	up to 52 weeks
Assessment of tolerability by physician and patient	verbal rating scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult male or female patients with HIV type 1 infection

Exclusion Criteria:

Counter-indications according to summary of product characteristics (SPC) for Viramune tablets
No persons under 18
Pregnancy and breast-feeding
Use of oral contraceptives
Use of drugs affecting CYP450 3A metabolism

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

HIV treatment centres and HIV out-patient facilities

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

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