CSP #512 - Options in Management With Anti-Retrovirals (OPTIMA) - Full Text View

Purpose

This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who have failed on conventional HAART (Highly Active Antiretroviral Therapy) regimens including all three classes of anti-HIV drugs. The first randomization will allocate patients to an intended 3-month antiretroviral drug-free period (ARDFP) or No ARDFP. The second randomization will allocate patients to Mega-ART (5+ drugs) or to Standard-ART (up to 4 drugs). The total study duration is 6.5 years with 5 years of intake and 1.5 year (minimum) of follow-up; median duration of patient follow-up is about 4 years. The target sample size is 390 patients and will provide 75% power to detect a 30% reduction in the hazard rate for the primary endpoint with mega-ART. Sixty-four sites will be participating in the trial--24 VA, 19 UK and 21 Canada.

Condition	Intervention
AIDS HIV Infections	Drug: No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART Drug: No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART Drug: Antiretroviral Drug-Free Period (ARDFP) and Standard-ART Drug: Antiretroviral Drug-Free Period (ARDFP) and Mega-ART

MedlinePlus related topics:

AIDS AIDS Medicines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

Official Title:	CSP #512 - Options in Management With Anti-Retrovirals (OPTIMA), Management of Patients With HIV Infection for Whom First and Second-Line Highly Active Anti-Retroviral Therapy Has Failed

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:	390
Study Start Date:	January 2001
Estimated Study Completion Date:	December 2006

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ability to provide informed consent
Age of 18 years or more
Serologic or virologic diagnosis of HIV infection
Failure of at least two different multi-drug regimens that include drugs of all 3 classes that the patient can tolerate or laboratory evidence of resistance to drugs in each of the 3 classes
Had at least 3 months of current ART and are still on treatment
Two most recent results (which can include screening) on current ART of:

CD4 count less than or equal to 300 cells/mm3 or less than or equal to 15% , and a plasma viral load greater than or equal to 5,000 copies/ml (Roche Amplicor, v1.0), or greater than or equal to 2,500 copies/ml (by bDNA: Bayer v3.0/Chiron v3.0 or PCR:Roche Amplicor Monitor/COBAS v1.5)

Exclusion Criteria:

Pregnancy, breast-feeding or planned pregnancy
Likelihood of poor protocol follow-up or if Mega-Art is not feasible (due to significant intolerance of many ARV drugs)
Serious, uncontrolled major opportunistic infection (OI) within 14 days of screening
Likelihood of early death due to non-HIV disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050089

Show 29 Study Locations

Sponsors and Collaborators

Department of Veterans Affairs

Medical Research Council

Canadian Institutes of Health Research (CIHR)

More Information

Study ID Numbers:	512
First Received:	November 20, 2002
Last Updated:	August 29, 2006
ClinicalTrials.gov Identifier:	NCT00050089
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

AIDS

HIV

randomized

human immunodeficiency virus

antiretrovirals

structured treatment interruptions

drug-free period

ART

HAART

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on October 07, 2008

Sponsors and Collaborators:	Department of Veterans Affairs Medical Research Council Canadian Institutes of Health Research (CIHR)
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00050089