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Anti-HIV Therapy Experienced and Virologically Failing
| Principal Investigator: | Donna Mildvan, MD | |
| Time frame of participation: | 48 weeks | |
| Number of participants needed: | Open | |
| Location of Study: | Beth
Israel Medical Center Clinical Trials Unit Baird Hall 350 East 17th Street, 3rd Floor New York, NY 10003 |
|
| Contact Number | (212) 420-4519 | |
| Compensation | Provided at entry into the study and at every regularly scheduled visit thereafter. |
Summary:
ACTG A5146; Evaluating the Impact of Therapeutic Drug Monitoring
(TDM) on Virologic Response to a Salvage Regimen.
This is a study looking at whether or not the use of therapeutic drug monitoring (TDM) benefits the virologic response of a salvage regimen.
Study steps:
Step1:
Salvage regimen selected based on virtual phenotype. Trough levels of
PIs obtained at week 2.
Step 2:
Patients with a normalized inhibitory quotient (NIQ) < 1
| Arm A: Standard of Care | |
| Arm B: Standard of Care + Therapeutic Drug Monitoring |
Patients with a normalized inhibitory quotient > 1
| Arm C: Observational | |
| Arm D: Discontinue study participation |
If HIV viral load is greater than 1000 a second virtual phenotype will
be obtained and patient will proceed to Step 3.
Step 3:
Begin second salvage regimen.
Obtain PI drug levels 2 weeks after initiation of regimen.
Option to receive dose adjustment of PI if NIQ < 1.
Criteria for Participation:
- HIV +
- At least 18 years of age
- Viral load greater than or equal to 2000
- Must currently be virologically failing their 2nd, 3rd, or 4th combination antiretroviral regimen, and stable greater than 12 weeks