HIV, Acquired Immune Deficiency Syndrome (AIDS) Infections and Infestations Human immunodeficiency virus (HIV)
Conditions
Interventions
1. Start a standard-ART regimen (up to four HIV drugs)
2. Start a mega-ART regimen (five or more HIV drugs)
3. Interrupt ART for 12 weeks then start a standard-ART regimen (up to four HIV drugs)
4.
Sponsors
University of British Columbia (Canada)
Medical Research Council (MRC) Clinical Trials Unit (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Age 18 years or more, either sex 3. HIV-1 infection confirmed by Enzyme-Linked Immuno-Sorbent Assay (ELISA) or Western Blot or detectable HIV viral load at any time 4. Failure of at least two different multi-drug regimens, which included drugs of all classes that the patient can tolerate 5. At least 3 months continuous HAART and still on treatment 6. Two most recent results (can include screening) on current Anti-Retroviral Therapy (ART) of either: 6.1. CD4 less than 100 plus plasma Viral Load (pVL) greater than 5000 copies, or 6.2. CD4 100 - 199 plus pVL greater than 10,000 copies *If VL testing available defined as either: failure to suppress pVL after 24 weeks of therapy, or rebound of at least 0.5 log10 in pVL from the nadir. In the era before pVL available defined as: a decline in the CD4 count over 50% from the peak, or progression of HIV disease.
Exclusion criteria
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 5. Any medical condition or current medication, in the opinion of the treating physician, which would contraindicate anti-HIV treatment as allocated in the trial Exclusion criteria for UK arm of trial added as of 07/02/2007: 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 ARV rugs) 3. Serious, uncontrolled major opportunistic infection (OI) within 14 days of screening 4. Likelihood of early death due to non-HIV disease *Patients exempt from second part of this question if entering option 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to new or recurrent AIDS-defining event or death and time to a new non-HIV related serious adverse event are main clinical outcomes. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to development of a new non-HIV related serious adverse event 2. Quality of life 3. Incidence of grade 3 or 4 clinical or laboratory adverse events 4. Changes in CD4 counts, viral load and resistance 5. Process measures including hematologic profiles, electrolytes, renal function, liver function and pancreatic function | — |
Countries
Canada, United Kingdom, United States of America
Outcome results
None listed