At a glance
ClinicalIndex Comparison Record- ✓HIV infection confirmed by serology or virology
- ✓Age ≥18 years
- ✓Documented failure of ≥2 multi-drug regimens including all 3 drug classes (NRTI, NNRTI, PI) or documented resistance to drugs in each class
- ✓Currently on ART for ≥3 months and still receiving treatment
- ✕Pregnancy or breast-feeding or planned pregnancy
- ✕Poor protocol adherence anticipated or Mega-ART not feasible due to significant intolerance of multiple ARV drugs
- ✕Serious, uncontrolled major opportunistic infection within 14 days of screening
- ✕Expected early death from non-HIV disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP and Standard ART vs Mega ART for AIDS and HIV Infections. Completed, enrolled 368 participants across 30 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Continuation or interruption of ART treatment
Standard therapy vs Intensified therapy
Continuation or interruption of ART treatment
Standard therapy vs Intensified therapy
Continuation or interruption of ART treatment
Standard therapy vs Intensified therapy
Continuation or interruption of ART treatment
Standard therapy vs Intensified therapy