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SHARE: Simple HAART With Abacavir, Reyataz, and Epivir

Primary Purpose

HIV Infections, Lipodystrophy

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
atazanavir (Reyataz)
ritonavir (Norvir)
Sponsored by
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, Reyataz, atazanavir, Norvir, ritonavir, Boosted, Lipodystrophy, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Whitman-Walker ClinicRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 23, 2007
Last Updated
October 30, 2007
Sponsor
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00426296
Brief Title
SHARE: Simple HAART With Abacavir, Reyataz, and Epivir
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
Collaborators
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Lipodystrophy
Keywords
HIV, Reyataz, atazanavir, Norvir, ritonavir, Boosted, Lipodystrophy, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
atazanavir (Reyataz)
Intervention Type
Drug
Intervention Name(s)
ritonavir (Norvir)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard A. Elion, MD
Email
drrelion@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Elion, MD
Organizational Affiliation
Whitman-Walker Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Whitman-Walker Clinic
City
Washington
State/Province
District of Columbia
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Elion, MD
Email
drrelion@aol.com
First Name & Middle Initial & Last Name & Degree
Richard A Elion, MD

12. IPD Sharing Statement

Learn more about this trial

SHARE: Simple HAART With Abacavir, Reyataz, and Epivir

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