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SHARE: Simple HAART With Abacavir, Reyataz, and Epivir

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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.

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
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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
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Locations
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
Principal Investigator: Richard A Elion, MD Whitman-Walker Clinic
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:
HIV Infections
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
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