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SHARE: Simple HAART With Abacavir, Reyataz, and Epivir

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Clinical Alliance for Research & Education - Infectious Diseases, LLC..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00426296
First Posted: January 24, 2007
Last Update Posted: November 1, 2007
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.
Collaborator:
GlaxoSmithKline
Information provided by:
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
  Purpose
SHARE: Simple HAART with Abacavir, Reyataz, and Epivir

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

Study Type: Interventional
Study Design: 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

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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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

ClinicalTrials.gov Identifier: NCT00426296     History of Changes
Other Study ID Numbers: COL102060
First Submitted: January 23, 2007
First Posted: January 24, 2007
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