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NCT00426296 Clinical Trial

SHARE: Simple HAART With Abacavir, Reyataz, and Epivir

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00426296
Other study ID # COL102060
Secondary ID
Status Recruiting
Phase Phase 4
First received January 23, 2007
Last updated October 30, 2007
Start date August 2006

Study information
Verified date October 2007
Source Clinical Alliance for Research & Education - Infectious Diseases, LLC.
Contact Richard A. Elion, MD
Email drrelion@aol.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

SHARE: Simple HAART with Abacavir, Reyataz, and Epivir

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

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• atazanavir (Reyataz)

• ritonavir (Norvir)

Locations
Country Name City State
United States Whitman-Walker Clinic Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
Clinical Alliance for Research & Education - Infectious Diseases, LLC. GlaxoSmithKline

Country where clinical trial is conducted

United States, 

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