SHARE: Simple HAART With Abacavir, Reyataz, and Epivir

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Clinical Alliance for Research & Education - Infectious Diseases, LLC..
Recruitment status was  Recruiting
Information provided by:
Clinical Alliance for Research & Education - Infectious Diseases, LLC. Identifier:
First received: January 23, 2007
Last updated: October 30, 2007
Last verified: October 2007
SHARE: Simple HAART with Abacavir, Reyataz, and Epivir

Condition Intervention Phase
HIV Infections
Drug: atazanavir (Reyataz)
Drug: ritonavir (Norvir)
Phase 4

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

Resource links provided by NLM:

Further study details as provided by Clinical Alliance for Research & Education - Infectious Diseases, LLC.:

Study Start Date: August 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00426296

Contact: Richard A. Elion, MD

United States, District of Columbia
Whitman-Walker Clinic Recruiting
Washington, District of Columbia, United States
Contact: Richard Elion, MD   
Principal Investigator: Richard A Elion, MD         
Sponsors and Collaborators
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
Principal Investigator: Richard A Elion, MD Whitman-Walker Clinic
  More Information Identifier: NCT00426296     History of Changes
Other Study ID Numbers: COL102060 
Study First Received: January 23, 2007
Last Updated: October 30, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Clinical Alliance for Research & Education - Infectious Diseases, LLC.:
Treatment Experienced

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Skin Diseases
Skin Diseases, Metabolic
Atazanavir Sulfate
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors processed this record on May 25, 2016