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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00426296
Date of registration: 23/01/2007
Prospective Registration: No
Primary sponsor: Clinical Alliance for Research & Education - Infectious Diseases, LLC.
Public title: SHARE: Simple HAART With Abacavir, Reyataz, and Epivir
Scientific 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
Date of first enrolment: August 2006
Target sample size:
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00426296
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Richard A Elion, MD
Address: 
Telephone:
Email:
Affiliation:  Whitman-Walker Clinic
Name:     Richard Elion, MD
Address: 
Telephone:
Email: drrelion@aol.com
Affiliation: 
Name:     Richard A. Elion, MD
Address: 
Telephone:
Email: drrelion@aol.com
Affiliation: 
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
HIV Infections
Lipodystrophy
Intervention(s)
Drug: ritonavir (Norvir)
Drug: atazanavir (Reyataz)
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
COL102060
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
GlaxoSmithKline
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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