Treatment Experienced Clinical Research Trials

The following clinical trials are currently open for enrollment, though the individual requirements and treatments for each study differ.

ACTG A5256

Single arm pilot trial to assess if adding maraviroc to an existing suppressive ART for 24 weeks will increase CD4 counts.

Requirements for this study include:

• On ART with virologic suppression for >48 wks
• Suboptimal CD4 recovery

Treatment will include:

• Open label Maraviroc

To become involved, contact Joan Riddle:

• Phone: 919-668-0175
• E-mail: riddl007@mc.duke.edu
• For more information about this study, follow this link to clinicaltrials.gov:
  http://www.clinicaltrials.gov/ct2/show/NCT00709111?term=HIV&id=actg+5256&fund=0&rank=1

ACTG A5241

ACTG A5241 is a randomized strategy study for treatment failure using optimized treatment that includes or omits NRTI.

Requirements for this study include:

• RNA >1000 on PI regimen
• Triple class ARV experience and/or resistance
• Must be naive to integrase inhibitor
• Tropism assay provided by study

Treatment will include:

• 13 possible treatment regimens based on tropism and phenotype results

To become involved, contact Midge Silberman, RN:

• Phone: 919-668-0177
• E-mail: slibe001@mc.duke.edu
• For more information about the study, follow this link to clinicaltrials.gov:
  http://www.clinicaltrials.gov/ct2/show/NCT00537394?term=HIV&recr=Open&id=actg+5241&age=1&fund=0&rank=1

Gilead 0144 - Ritonavir Boosted Elvitegravir vs. Raltegravir

Double blind safety and efficacy study of EVG/r vs RAL in treatment experienced subjects.

Requirements for this study include:

• Viral load of greater than 1000
• Treatment experienced
• Documented resistance of 6 months with at lease two classes of ARVs
• Eligible to receive PI/r based on phenotype

To become involved, contact Debbie McMullen:

• Phone: 919-668-3759
• E-mail: mcmul006@mc.duke.edu