PMID- 17453591
OWN - NLM
STAT- MEDLINE
DCOM- 20070726
LR  - 20071203
IS  - 0954-0121 (Print)
IS  - 0954-0121 (Linking)
VI  - 19
IP  - 4
DP  - 2007 Apr
TI  - A randomised control trial of structured interrupted generic antiretroviral 
      therapy versus continuous therapy in HIV-infected individuals in Southern India.
PG  - 507-13
AB  - This randomised control trial, conducted in Chennai, India, compared structured 
      interrupted therapy (SIT) and continuous therapy (CT) in relation to immunologic 
      and virologic outcomes, adverse events (AEs) and cost of therapy. ART-naive adult 
      HIV1-infected participants with CD4 counts 50-350 cells/mm(3), and plasma viral 
      load (PVL)>5000 copies/mL were enrolled and placed on Indian-manufactured generic 
      ART: zidovudine(AZT)/stavudine(d4T)+lamivudine(3TC)+efavirenz(EFV). After at 
      least six months of continuous therapy, subjects were randomised to SIT 
      (one-week-on/one-week-off cycles) or CT. The primary end-point was the proportion 
      of subjects maintaining CD4>200 cells/mm(3) at six and 12 months after 
      randomisation. Secondary end-points were effective viral suppression (PVL<400 
      copies/mL), AEs and cost. All analyses used intention-to-treat methodology. Of 40 
      participants (69% male; mean age 36+/-7; median baseline CD4 and PVL: 162 
      cell/mm(3)and 259,000 copies/mL), 17 were randomised to SIT and 18 to CT. At 
      randomisation, median CD4s for SIT and CT were 378 cells/mm(3) and 357 
      cells/mm(3), respectively. All participants had PVL<400 copies/mL at time of 
      randomisation. Median CD4 six months after randomisation was 498 cells/mm(3) and 
      417 cells/mm(3) for SIT and CT respectively. All participants had CD4>200 
      cells/mm(3). One participant on CT and two on SIT had sustained PVL>400 
      copies/mL. There were no serious AEs or deaths. Structured interrupted therapy 
      cost was half of CT. Structured interrupted therapy was effective at maintaining 
      CD4 above 200 cells/mm(3). Adverse events were comparable in both groups, with 
      50% reduction in cost for SIT. Further research on such strategies may benefit 
      resource-constrained settings.
FAU - Kumarasamy, N
AU  - Kumarasamy N
AD  - YRG Center for AIDS Research and Education, VHS, Chennai, India. 
      kumarasamy@yrgcare.org
FAU - Flanigan, T P
AU  - Flanigan TP
FAU - Vallabhaneni, S
AU  - Vallabhaneni S
FAU - Cecelia, A J
AU  - Cecelia AJ
FAU - Christybai, P
AU  - Christybai P
FAU - Balakrishnan, P
AU  - Balakrishnan P
FAU - Yepthomi, T
AU  - Yepthomi T
FAU - Solomon, S
AU  - Solomon S
FAU - Carpenter, C C J
AU  - Carpenter CC
FAU - Mayer, K H
AU  - Mayer KH
LA  - eng
GR  - 5U01 AI 038858/AI/NIAID NIH HHS/United States
GR  - D43TW00237/TW/FIC NIH HHS/United States
GR  - P30 AI42853/AI/NIAID NIH HHS/United States
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - AIDS Care
JT  - AIDS care
JID - 8915313
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Drugs, Generic)
SB  - IM
MH  - Adult
MH  - Anti-HIV Agents/adverse effects/*therapeutic use
MH  - Antiretroviral Therapy, Highly Active
MH  - Drugs, Generic/adverse effects/*therapeutic use
MH  - Female
MH  - HIV Infections/*drug therapy/mortality
MH  - Humans
MH  - India/epidemiology
MH  - Male
MH  - Pilot Projects
EDAT- 2007/04/25 09:00
MHDA- 2007/07/27 09:00
CRDT- 2007/04/25 09:00
PHST- 2007/04/25 09:00 [pubmed]
PHST- 2007/07/27 09:00 [medline]
PHST- 2007/04/25 09:00 [entrez]
AID - 777251527 [pii]
AID - 10.1080/09540120701213849 [doi]
PST - ppublish
SO  - AIDS Care. 2007 Apr;19(4):507-13. doi: 10.1080/09540120701213849.