A5241
The
Optimized Treatment that Includes or Omits NRTIs (OPTIONS)
Trial: A Randomized Strategy Study for HIV-1-Infected
Treatment-Experienced Subjects Using the cPSS to Select
an Effective Regimen
Purpose of this Study: To
compare treatment success (defined as the probability
of not experiencing virologic failure or discontinuation
of NRTI strategy by week 48) between subjects taking
a new regimen of more than two active agents (defined
by a cPSS >2.0) that includes versus excludes NRTIs.
Requirements to Enter Study:
- Inclusion Criteria:
1. >= 18 years
2. Triple class experienced or 1 mutation in both
the NRTI and NNRTI class
3. Current PI regimen
4. HIV RNA >= 1000 copies/mL
5. Adequate safety labs
6. Karnofsky >= 70%
- Exclusion Criteria:
1. Prior integrase inhibitor
2. Chronic active hepatitis B
Treatment: Enfuvirtide, Maraviroc,
Raltegravir, Darunavir, Tipranavir, and Etravirine
will be provided by the study. Neither RTV nor any
NRTI’s will be provided by the study.
Step 1 Resistance and Co-Receptor Tropism
Testing and Regimen Selection (Up to 60 days)
- Genotype/phenotype/ tropism assays performed
- PSS determined for each agent
- Core team identifies regimen with a cPSS >2.0
- Regimen and NRTI recommendations communicated
to site
- Subject and site investigator select study regimen
and NRTIs from among options identified by core
team.
Step 2 cPSS-Based Novel Regimen (Study
Regimen)
- Randomization if cPSS >2.0 (Stratified by
ENF experience, use of MVC on study, and NRTI
susceptibility)
o Arm A: Study Regimen plus NRTIs for 48
weeks (177 subjects may be enrolled)
o Arm B: Study Regimen without NRTIs for
48 weeks (177 subject may be enrolled)
Registration if cPSS =2.0 (Observational
Arm)
o Arm C: Study Regimen plus NRTIs for 48 weeks
(up to 100 subjects may be enrolled)
Duration of Study: Part 1: 2 months, Part 2:
12 months, totaling 14 months
For
more information contact:
Study
Contacts
Joseph
Quinn, RN (215) 349-8092
