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. Author manuscript; available in PMC: 2013 Sep 16.
Published in final edited form as: AIDS Rev. 2013 Jan-Mar;15(1):15–24.

Table 1.

*: Major Studies† of Structured HIV Treatment Interruption

Study Location(s), Year(s)‡ Total (Interruption) No. of Patients Interruption Criteria Follow-Up (Years) Major Results
Major Studies Demonstrating a Disadvantage of Structured HIV Treatment Interruption
Structured: CD4 Guided§
SMART[61] Copenhagen, London, Sydney 2002–2006 5472 (2720) Stop at CD4>350, restart at CD4<250; repeat throughout study 1.3 OI or Death 3.3 /100 person-years in interruption group; 1.3 in controls (hazard ratio 2.6)
LOTTI[62] Italy ** 329 (165) Stop; restart at CD4≤350, stop at CD4>700; repeat throughout study 4.2 OI/death/admission 12% in interruption group; 12% in controls (OR 1.05)
TRIVACAN[63] Ivory Coast, 2002 326 (216) Stop at CD4>350, restart at CD4<250; repeat 1.7 Severe Morbidity 17.7 /100 person-years in interruption group; 6.7 in controls (p=0.001)
TRIESTAN[64] Netherlands ** 71 (46) Stop; restart at CD4<300, one cycle 0.9 VL 4.6 log in interruption group; undetectable in controls
Structured: CD4/VL Guided§
TIBET[65] Spain, Italy 2001–2002 201 (100) Stop; restart at VL>100,000 or CD4<350, repeat 2 years 1.8 Median CD4 520 in interruption group; 789 in controls (p<0.001)
Leon et al.[66] Barcelona, Spain 2002–2005 121 (83) Stop; restart at VL>50,000 or CD4<350, repeat 2 years 2 Median CD4 count significantly lower than baseline in interruption group (p<0.0001); not lower in controls (p=0.68)
Structured: Timed Cycle§
DART[67] Uganda, Zimbabwe 2004–2006 813 (408) 12 weeks off/on therapy throughout study 1 First WHO stage 4 events 6.4/100 person-years in interruption group; 2.4 in controls (p=0.007)
TRIVACAN[31] Ivory Coast, 2002 422 (315) 2 months off/4 months on therapy, repeat throughout study 2 14.6% CD4<350 in interruption group; 5.6% in controls (LBCI of the difference = 13.9)
Major Studies Inconclusive on Outcomes of Structured HIV Treatment Interruption
Structured: CD4 Guided§
BASTA[68] Italy 2003 69 (46) Stop; restart at CD4≤400, stop at CD4>800, repeat throughout study 64 Weeks Proportion with CD4>400 not statistically different
Structured: Timed Cycle§
Canadian HIV Trials Network 164[27] Canada 2001–2004 147 (68) Stop failing regimen for 12 weeks; start salvage regimen; one cycle 3 Months No increase in proportion with sustained VL<50
Reynolds et al.[26] Kampala, Uganda 2002–2005 135 (Arm 1: 32; Arm 2: 52) Arm 1: 7 days on/7 days off, repeat throughout study
Arm 2: 5 days on/2 days off, repeat throughout study		 72 Weeks Arm 1: 31% failure, closed
Arm 2: 12% failure in interruption group; 22% in controls
Structured: CD4 Guided and Timed Cycle§
Staccato[25] Thailand, Switzerland, Australia 2003–2005 430 (284) Arm 1: Stop; restart at CD4<350 for ≥12 weeks, stop at CD4>350, repeat throughout study;
Arm 2: 1 week on, 1 week of; repeat throughout study		 1.8 Years Arm 1: 91% reached VL<50 in interruption group; 92% in controls (p=0.90)
Arm 2: Stopped due to high failure rate
HIV-NAT[23,24] Thailand 2001–2004 74 (26, 23) Arm 1: Stop; restart for ≥ 12 weeks if CD4<350 or drop >30% from baseline; Stop if CD4>350 or up ≥70% from baseline, repeat for 2 years
Arm 2: 1 week on/1 week off, repeat for 2 years		 108 Weeks Arm 1: 100% CD4 ≥350 in interruption group; 96% in controls, median CD4=489 in interruption; 661 in controls, (p=0.03);
Arm 2: Discontinued due to high rate of failure
*

Table is sorted by descending number of patients within each category. Abbreviations: No.-number, OI- opportunistic infections, OR- odds ratio, VL- viral load, WHO- World Health Organization, LBCI- lower bound of 95% confidence interval.

†

Studies included (i) had a control group with no treatment interruption; (ii) had >40 adult participants; (iii) were not limited to patients with multi-drug resistance; and (iv) were completed after 2000.

‡

Year(s) listed are dates of conduction of the study.

§

See text for additional details.

**

Dates not available.