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SHARE: Simple HAART With Abacavir, Reyataz, and Epivir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00426296
Recruitment Status : Unknown
Verified October 2007 by Clinical Alliance for Research & Education - Infectious Diseases, LLC..
Recruitment status was:  Recruiting
First Posted : January 24, 2007
Last Update Posted : November 1, 2007
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Clinical Alliance for Research & Education - Infectious Diseases, LLC.

Brief Summary:
SHARE: Simple HAART with Abacavir, Reyataz, and Epivir

Condition or disease Intervention/treatment Phase
HIV Infections Lipodystrophy Drug: atazanavir (Reyataz) Drug: ritonavir (Norvir) Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426296


Contacts
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Contact: Richard A. Elion, MD drrelion@aol.com

Locations
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United States, District of Columbia
Whitman-Walker Clinic Recruiting
Washington, District of Columbia, United States
Contact: Richard Elion, MD       drrelion@aol.com   
Principal Investigator: Richard A Elion, MD         
Sponsors and Collaborators
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
GlaxoSmithKline
Investigators
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Principal Investigator: Richard A Elion, MD Whitman-Walker Clinic

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ClinicalTrials.gov Identifier: NCT00426296     History of Changes
Other Study ID Numbers: COL102060
First Posted: January 24, 2007    Key Record Dates
Last Update Posted: November 1, 2007
Last Verified: October 2007
Keywords provided by Clinical Alliance for Research & Education - Infectious Diseases, LLC.:
HIV
Reyataz
atazanavir
Norvir
ritonavir
Boosted
Lipodystrophy
Treatment Experienced
Additional relevant MeSH terms:
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Lipodystrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Ritonavir
Atazanavir Sulfate
Abacavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors