N/A
Completed N=368
CSP #512 - Options in Management With Anti-Retrovirals
Source: ClinicalTrials.gov NCT00050089 ↗Enrolled (actual)
368
Serious AEs
63.1%
Results posted
Feb 2014
Primary outcomePrimary: Number of Participants With New or Recurrent AIDS Event, or Death — 83; 82 participants — p=0.69
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With New or Recurrent AIDS Event, or Death |
46; 41; 35; 35 | 0.87 |
| SECONDARY Number of Participants With a New, Non-HIV Related Serious Adverse Event |
97; 88 | 0.92 |
| SECONDARY Number of Participants With New, Non-HIV Related Serious Adverse Event |
84; 92 | 0.68 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00050089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.