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:

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

History of Changes

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: 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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Abacavir Ritonavir Abacavir sulfate Atazanavir 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 (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

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


ClinicalTrials.gov Identifier:	NCT00426296 History of Changes
Other Study ID Numbers:	COL102060
Study First Received:	January 23, 2007
Last Updated:	October 30, 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

ClinicalTrials.gov processed this record on July 24, 2017

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