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Session 15 Oral Abstract Presentations
Treatment Strategies
Session Day and Time: Wednesday 11:15 am - 12:45 pm
Presentation Time: 11:45
Room: Auditorium


66
ISS-PART: A Prospective, Randomized, Multi-center Clinical Trial of Intermittent Therapy in HIV+ Subjects with Persistent Suppression of Viral Replication
S. Vella*, M. Giuliano, L. Palmisano, R. Bucciardini, M. Andreotti, R. Arcieri, V. Fragola, C. Galluzzo, L. Weimer, MF Pirillo, R.Amici, E.Germinario, Italian ISS-PART Clinical Centers
Inst Superiore di Sanità, Rome, Italy

Background: The role of intermittent antiretroviral therapy in chronic HIV infection is still controversial.

Methods: ISS-PART is an ongoing prospective, randomized, multicenter clinical trial of STI in subjects with chronic HIV infection and stable control of viral replication. Subjects are randomized to: 1) Arm A: Standard of care for 24 months (mos), and 2) Arm B : Intermittent antiretroviral treatment (5 STI of 1-, 1-, 2-, 2-, and 3-mos duration, each one followed by 3 mos on therapy). Study endpoint is the proportion of pts with CD4 > 500/mmc at month 24.

Results: A total of 273 (136 in arm B) subjects was enrolled. Mean age 40.1 yrs; sex F (30.3%); NNRTI-including regimens 67.6%; mean HAART duration 26 mos; median CD4 at randomization 691/mmc; median CD4 pre-HAART 393/mmc.

After a median follow up of 6 mos, dropout rate is 3.6% in arm A and 13.2% in arm B. Preliminary observations show the following:

 

 

1st STI ( 1 mo)

2nd STI (1 mo)

3rd STI ( 2 mos)

 

134 pts

92 pts

34 pts

Median rebound in HIV-RNA (log)

+2.3

+2.1

+2.2

Subjects with no HIV-RNA rebound

33 (24.6%)

25 (27.2%)

3 (8.8%)

Median decrease in CD4 absolute number

-72

-60

-147

Subjects with > 25% reduction in CD4

26 (19.4%)

15 (16.3%)

7 (20.6%)

 

At therapy reinitiation, after each STI, median CD4 have returned to baseline values. After the 1st, 2nd and 3rd STI 88.9%, 96.8% and 100% of patients have achieved HIV RNA < 400 copies/ml. Genotypic resistance tests performed during STIs have shown resistance associated mutations in 29 (21.3%) patients of arm B at any time off therapy. All but two achieved viremia levels below 400 copies after the reinitiation of their pre-STI antiretroviral regimen.

Conclusions: Overall response to therapy reinitiation was satisfactory; however, a longer follow-up is required to assess the clinical significance of mutations in the rebounding virus.