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
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
ClinicalTrials.gov Identifier:
NCT00426296
First received: January 23, 2007
Last updated: October 30, 2007
Last verified: October 2007
  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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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
  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 ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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.:
HIV
Reyataz
atazanavir
Norvir
ritonavir
Boosted
Lipodystrophy
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lipodystrophy
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lipid Metabolism Disorders
Metabolic Diseases
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases
Skin Diseases, Metabolic
Slow Virus Diseases
Virus Diseases
Atazanavir
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014