Tissue Drug Levels of HIV Medications | NCT01490346

Studies
Tissue Drug Levels of HIV Medications

NCT01490346

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Jun 3, 2015Estimated

Enrollment

22Actual

Phase

Not provided

Conditions

Human Immunodeficiency Virus

Interventions

Initiation of anti-retroviral therapy

Countries

United States

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

ID	Type	Description	Link
P01AI074340	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2015

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

Sep 2008

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Oct 24, 2011

First Submission Date that Met QC Criteria

Dec 8, 2011

First Posted Date

Dec 13, 2011Estimated

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

Jun 1, 2015

Last Update Posted Date

Jun 3, 2015Estimated

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to find out why HIV continues to make copies in people taking HIV drugs. The investigators want to know if the medications most people use to treat HIV get into the lymphatic tissue where HIV persists.

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

Retention

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ART treated individuals			Drug: Initiation of anti-retroviral therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Initiation of anti-retroviral therapy	Drug	Subjects begin taking a preferred initial anti-retroviral regimens as determined by their primary care provider. Intracellular levels of those medications are measured.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intracellular antiretroviral drug concentrations		Measured at baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months & 6 months

Secondary Outcomes

Measure	Description	Time Frame
Evidence of HIV replication in blood and lymphoid tissue		Measured at baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, & 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV+
Treatment naive or >30 days off ARV therapy
Documented sensitivity to prescribed antiretrovirals
Age ≥ 18 years
Negative pregnancy test for eligible women of childbearing potential
Ready to start ARV therapy

Exclusion Criteria:

Contraindications to surgical & endoscopy procedures (as judged by PI)
Psychiatric or psychological illness that would make adherence to protocol procedures unlikely
Pregnancy

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-positive individuals beginning anti-retroviral treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Timothy Schacker, MD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55455	United States

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