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

First Received on January 23, 2007. Last Updated on October 30, 2007 History of Changes

Sponsor:	Clinical Alliance for Research & Education - Infectious Diseases, LLC.
Collaborator:	GlaxoSmithKline
Information provided by:	Clinical Alliance for Research & Education - Infectious Diseases, LLC.
ClinicalTrials.gov Identifier:	NCT00426296

Purpose

SHARE: Simple HAART with Abacavir, Reyataz, and Epivir

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

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lamivudine Abacavir Ritonavir Abacavir succinate Abacavir sulfate BMS 232632 Atazanavir sulfate

U.S. FDA Resources

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

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:

HIV Infections
Acquired Immunodeficiency Syndrome
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders

Metabolic Diseases
Ritonavir
Atazanavir
Abacavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012