SHARE: Simple HAART With Abacavir, Reyataz, and Epivir | NCT00426296

Studies
SHARE: Simple HAART With Abacavir, Reyataz, and Epivir

NCT00426296

Sponsor

Clinical Alliance for Research & Education - Infectious Diseases, LLC.

Status

Unknown status

Last Update Posted

Nov 1, 2007Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

HIV Infections
Lipodystrophy

Interventions

atazanavir (Reyataz)
ritonavir (Norvir)

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

Official Title

An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of a Fixed-Dose Combination of Abacavir 600 mg/Lamivudine 300 mg Once-Daily in Combination With Atazanavir 300 mg + Ritonavir 100 mg Once-Daily in Antiretroviral-Naïve HIV-1 Infected Subjects With Continuing Evaluation of Abacavir/Lamivudine Plus Atazanavir 400 mg for Maintenance Over an Additional 48 Weeks

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 23, 2007

First Submission Date that Met QC Criteria

Jan 23, 2007

First Posted Date

Jan 24, 2007Estimated

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 30, 2007

Last Update Posted Date

Nov 1, 2007Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

Description Module

Brief Summary

SHARE: Simple HAART with Abacavir, Reyataz, and Epivir

Detailed Description

Open-label, multicenter study of ABC/3TC + ATV in subjects who have completed at least 24 weeks of treatment on ABC/3TC+ATV/RTV as their first line regimen and have plasma HIV-1 RNA <50 copies/mL at entry

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Currently taking abacavir/lamivudine (Epzicom) in combination with atazanavir (Reyataz) boosted with ritonavir (Norvir) as first antiretroviral regimen
Viral load <50 copies/ml

Exclusion Criteria:

Viral load >50 copies/ml
Having taken more than one antiretroviral regimen

Accepts Healthy Volunteers

Not provided

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Richard A. Elion, MD	Contact			drrelion@aol.com

Overall Officials

Name	Affiliation	Role
Richard A Elion, MD	Whitman-Walker Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Whitman-Walker Clinic	Recruiting	Washington D.C.	District of Columbia		United States

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D008060	Lipodystrophy

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
D000069446	Atazanavir Sulfate
D019438	Ritonavir

Ancestor Terms

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009842	Oligopeptides

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
atazanavir (Reyataz)	Drug
ritonavir (Norvir)	Drug