SNAP: Switching Nucleoside Analogues Protocol - Lipoatrop... | NCT00225082

Studies
SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function

NCT00225082

Sponsor

Northwestern University

Status

Completed

Last Update Posted

Oct 5, 2010Estimated

Enrollment

12Actual

Phase

Not provided

Conditions

HIV Infection

Interventions

Nucleoside analogue switch

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

Status Module

Record Verification Date

Oct 2010

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

Nov 2004

Primary Completion Date

Dec 2006Actual

Completion Date

Oct 2007Actual

First Submitted Date

Sep 21, 2005

First Submission Date that Met QC Criteria

Sep 21, 2005

First Posted Date

Sep 23, 2005Estimated

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

Oct 4, 2010

Last Update Posted Date

Oct 5, 2010Estimated

Name	Class
Abbott	INDUSTRY

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

HIV infected subjects receiving antiretroviral treatment for greater than 6 years with be evaluated for clinical lipoatrophy and mitochondrial function after switching nucleoside analogues from stavudine (d4T) to tenofovir treatment and after 4.

Hypothesis: Tenofovir therapy will increase peripheral fat content as assessed by DEXA and mitochondrial function at 48 weeks.

Detailed Description

HIV infected subjects receiving antiretroviral treatment (lopinavir/ritonavir, stavudine, and lamivudine) for greater than 6 years through the Abbott M97-720 protocol with be evaluated for clinical lipoatrophy and mitochondrial function prior to switching nucleoside analogues from stavudine (d4T) to tenofovir and after 48 weeks or tenofovir treatment.

Subjects with or without lipoatrophy are eligible for the study. Adipose tissue biopsies to measure mitochondrial function, metabolic laboratory tests, and DAXA scans and clinical evaluations of lipodystrophy will be performed at Entry and after 48 weeks of tenofovir treatment.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

12Actual

Name	Type	Description	Arm Group Labels	Other Names
Nucleoside analogue switch	Drug	stavudine switched to tenofovir

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV infection
Receiving Kaletra, stavudine, and lamivudine for greater than 6 years (through Abbott M97-720 study)
Planning to switch from stavudine to tenofovir

Exclusion Criteria:

Will continue to receive stavudine

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert L Murphy, MD	Northwestern University	Study Chair
Mariana Gerschenson, Ph.D.	University of Hawaii	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University		Chicago	Illinois	60611	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19321503	Result	Gerschenson M, Kim C, Berzins B, Taiwo B, Libutti DE, Choi J, Chen D, Weinstein J, Shore J, da Silva B, Belsey E, McComsey GA, Murphy RL. Mitochondrial function, morphology and metabolic parameters improve after switching from stavudine to a tenofovir-containing regimen. J Antimicrob Chemother. 2009 Jun;63(6):1244-50. doi: 10.1093/jac/dkp100. Epub 2009 Mar 25.

ID	Term
D015658	HIV Infections
D008060	Lipodystrophy

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