human Immunodeficiency virus (HIV) infection.
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Medical Research Council Clinical Trials Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Ability to provide Informed Consent 2) Age of 18 years or more 3) Serologic or virologic diagnosis of HIV infection 4) Had failure* of at least two different multi-drug regimens that included drugs of all 3 classes that the patient can tolerate Or laboratory evidence of resistance** to drugs in each of the 3 classes 5) Had at least 3 months of current ART and is still on treatment (unless a new failure*, defined as (c) below) 6) Two most recent results (which can include screening) on current ART of : CD4+ T-cell count £ 300 cells/mm3 or £ 15%, and plasma viral load ³ 5,000 copies/ml (by Roche Amplicor, v1.0) or ³ 2,500 copies/ml (by bDNA: Bayer v3.0/Chiron v3.0, or PCR: Roche Amplicor Monitor/COBAS v1.5) *Failure (since availability of viral load tests) is defined as: (a) failure to suppress plasma viral load after 24 weeks of therapy, or (b) a rebound of at least 0.5 log10 in plasma viral load from nadir, or (c) less than 0.5 log10 drop by (bDNA: Bayer v 3.0/Chiron v3.0, or PCR: Roche AmplicorMonitor/COBAS v1.5) or less than 1.0 log10 drop (Roche Amplicor v1.0), in plasma viral load after at least 4 weeks continuous treatment with a current new multi-drug regimen OR (in the therapeutic era before viral load testing was available) failure is defined as: CD4 decline >50% from peak treatment response, or below pretreatment level, or clinical progression of HIV disease. ** Resistance (this could be from screening susceptibility test) is defined either as: (a) genotypic (defined as the presence of primary mutations associated with resistance to at least 2 drugs in each class), OR (b) phenotypic evidence of 3-class resistance Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: b. Exclusion Criteria: 1)Pregnancy, breast-feeding or planned pregnancy 2)Likelihood of poor protocol follow-up or if Mega-ART is not feasible (due to significant intolerance of many ART drugs) 3)Serious, uncontrolled major opportunistic infection (OI) within 14 days of screening 4)Likelihood of early death due to non HIV-disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study will compare different strategies for the management of patients with HIV infection for whom first and second line HAART has failed. The OPTIMA study aims to evaluate (a) the effect of mega-ART compared to standard-ART and (b) the effect of an intended 3-month ARDFP compared to no ARDFP in the management of patients for whom previous HAART therapy has failed. ;Secondary Objective: The impact of mega-ART and ARDFP on cost and Quality Adjusted Life Years will be determined; lifetime costs and outcomes will be modelled to determine whether these strategies are cost-effective. ;Primary end point(s): Primary Endpoint: Time to new or recurrent AIDS event or Death Secondary Endpoint: Time to development of a new non-HIV related serious adverse event Other outcomes that will be assessed are: 1. Quality of Life 2. Incidence of grade 3 or 4 clinical or laboratory adverse events 3. Changes in CD4 counts, viral load and resistance 4. Process measures including haematology profiles, electrolytes, renal function, liver function, pancreatic function, and lipid levels) | — |
Countries
Spain
Outcome results
None listed