SHARE: Simple HAART With Abacavir, Reyataz, and Epivir
Information source: Clinical Alliance for Research & Education - Infectious Diseases, LLC.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Lipodystrophy
Intervention: atazanavir (Reyataz) (Drug); ritonavir (Norvir) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Clinical Alliance for Research & Education - Infectious Diseases, LLC. Official(s) and/or principal investigator(s):
Richard A Elion, MD, Principal Investigator, Affiliation: Whitman-Walker Clinic
Overall contact:
Richard A. Elion, MD, Email: drrelion@aol.com
Summary
SHARE: Simple HAART with Abacavir, Reyataz, and Epivir
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Richard A. Elion, MD, Email: drrelion@aol.com
Whitman-Walker Clinic, Washington, District of Columbia, United States; Recruiting
Richard Elion, MD, Email: drrelion@aol.com
Richard A Elion, MD, Principal Investigator
Additional Information
Starting date: August 2006
Last updated: October 30, 2007
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