NCT00050089

CSP #512 - Options in Management With Anti-Retrovirals

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 368 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who have failed on conventional Highly Active Antiretroviral Therapy (HAART) 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.

Detailed description

Primary Hypothesis: Compared to patients in Standard Antiretroviral Therapy (ART), patients in Mega-ART assuming full compliance, will experience a 30% reduction in the hazard of reaching a clinical endpoint (AIDS event or death). Secondary Hypotheses: Time to development of a new, non-HIV related serious adverse event, health related quality of life, the incidence of grade 3 or 4 clinical or laboratory adverse events and changes in virological and immunological markers (CD4 cell count, viral load, resistance profiles) will vary between the different treatment strategies. Interventions: Eligible patients will be randomized to one of four treatment strategy arms: 1. No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART 2. No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART 3. Antiretroviral Drug-Free Period (ARDFP) and Standard-ART 4. Antiretroviral Drug-Free Period (ARDFP) and Mega-ART Note: The 'first' randomization will be ARDFP vs No ARDFP. Patients randomized to No ARDFP will receive their 'second' randomization at the same time. However, patients randomized to an Antiretroviral Drug Free Period (ARDFP) will receive their 'second' randomized assignment (Standard or Mega-ART) at the end of the ARDFP. Note: All Serious Adverse Events were coded using the MedDRA coding dictionary; other (not serious) Adverse Events were collected as part of the study but were not coded using MedDRA or any other standardized coding dictionary. This is the first trial of a Tri-National collaboration effort between the UK MRC, the Canadian CIHR and the VA CSP. The OPTIMA Trial was reviewed and approved by CSEC on October 12, 2000. The pre-kickoff meeting was held on March 21, 2001 in Washington, DC. The VA study kickoff meeting was held in Dallas, TX on May 16-18, 2001 and the Canadian kickoff was held in Toronto on May 29, 2001. The UK will have individual site initiation. As of October 17, 2005 there have been 357 patients enrolled in OPTIMA, at 64 sites in the three countries (279 in the VA, 41 in Canada and 37 in the UK). To date there are 64 sites actively participating in the study (24 in the VA, 19 in UK and 21 in Canada). Last date of patient follow-up was December 31, 2007.

Conditions

• AIDS
• HIV Infections

Interventions

Type	Name	Description
OTHER	No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP	Continuation or interruption of ART treatment
DRUG	Standard ART vs Mega ART	Standard therapy vs Intensified therapy
OTHER	No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP	Continuation or interruption of ART treatment
DRUG	Standard ART vs Mega ART	Standard therapy vs Intensified therapy
OTHER	No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP	Continuation or interruption of ART treatment
DRUG	Standard ART vs Mega ART	Standard therapy vs Intensified therapy
OTHER	No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP	Continuation or interruption of ART treatment
DRUG	Standard ART vs Mega ART	Standard therapy vs Intensified therapy

Timeline

• Start date: 2001-01-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2002-11-22
• Last updated: 2015-04-23
• Results posted: 2014-02-13

Locations

30 sites across 2 countries: United States, Puerto Rico