ETHICS COMMITTEE NATIONAL AIDS RESEARCH INSTITUTE (INDIAN COUNCIL OF MEDICAL RESEARCH) Plot No. 73, `G' Block, MIDC, Bhosari, Pune

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1 Plot o. 73, `G' Block, MIDC, Bhosari, Pune org S ammpune(q)hotmai1. com asim.human(d). .com San j ay. rutu j an gmai l.c o m shrotr] IIrnu ct, mail^:rnn ikpalnu,hotmail.com nirmalahiremathyahoo.co.in directornsofosh.org kakrani e,hotmail.com Medicine rparani ape(a,nariindia. ore To, Dr. Sheela Godbole Investigator of Record, HPT, Scientist `D', ARI Reference : Your letter ARI/HPTO52/13-14/009, dated 15 January 2013 Date: 20 February 2013 Subject: Annual review and Approval of the study protocol and other related documents submitted for annual continuing review Protocol Title: HPT 052: "A randomized trial to evaluate the effectiveness of antiretroviral therapy plus HIV primary care versus HIV primary care alone to prevent the sexual transmission of HIV- 1 in Serodiscordant couples." Protocol Version & Date: 3.0, dated 20 ovember 2006 Principal Investigator : Dr. S.M. Mehendale, MD, MPH Investigator of Record : Dr. S. V. Godbole, MD Dear Dr. S.V. Godbole, The documents of above-mentioned study have been reviewed and discussed in the 48th Ethics Committee Meeting held on 06th February 2013 at Conference Hall, ew Building, ARI. The ARI Ethics Committee hereby grants an annual continuation of approval to the above mentioned study and the following documents: A) HPT 052 study related documents for annual review and continuation of approval o. ame of the Document Version Date 1. HPT 052 Protocol version 3.0 ovember 20, Letter of Amendment # 1 August 7, Letter of Amendment # 2 March 20, Letter of Amendment # 3 July 30, Letter of Amendment # 4 December 9, Letter of Amendment # 5 May 10, 2011 Page I of 4 dryogeshnehetengmai 1. com

2 Plot o. 73, `G' Block, MIDC, Bhosari, Pune ethics S ammpune c hotmai].com asim.human n,cmail.com San iay. rutuiaapzmail.com shrotriapatna(u., gmai l.com ikpal cr,hotmail.com nirma1ahiremath(a_yahoo.co.in kakrani@hotmail.com Medicine rparanjape a nariindia.org 7. Clarification Memo #1 August 26, Clarification Memo #2 August 31, 2011 HPT English Short Consents 9. Index Case and Partner Screening version 1.1 August 4, Index Case Enrollment version 1.1 August 4, Partner Enrollment version 1.1 August 4, Index Case Pregnancy version 1.1 August 4, Specimen Storage version 1.1 August 4, Information Sheet # 1 (English, Marathi) (2 Documents) Information Sheet # 2 (English, Marathi) (2 Documents) Information Sheets version 1.0 May 22, 2008 version 2.1 October 21, Information Sheet # 2 (Hindi) version Additional ew Information sheet on Kaletra/Aluvia - English Additional ew Information sheet on Kaletra/Aluvia - Marathi Additional ew Information sheet on Kaletra/ Aluvia - Hindi Participant Letter / Information Sheet (English Hindi & Marathi) June 24, 2009 July 6, 2009 July 17, 2009 version 1.1 August 26, Participant Letter #2 (DSMB 21. Recommendation) - English, Version 1.1 June 02, 2011 Marathi, Hindi Participant Information Sheet for 22. change in Contact details of EC Chairman and IoR - English and '`Iurathi - Version 1.0 January 16, 2012 Participant Information Sheet for 23. change in Contact details of EC Version 1.0 September 10, 2012 Chairman and IoR - Hindi Page 2of 4 dryogeshnehete(z gmail.com

3 Plot o. 73, `G' Block, MIDC, Bhosari, Pune eth i c kem hrcp une. org S ammpune(d?hotmail.com asim.human(a^gmail.com Saniay. rutuja( gmai1.com shrotriaparnan cmail.com B iotechnologist ikpalc hotmail.com nirmalahircmathnyahoo.co.in kakrani o,hotmail.com iv,edicine rparaniape n,nariindia.org Other HPT 052 Documents Advertisement for media and public 24. distribution(english, Marathi, Hindi) version 1.1 July 10, 2008 (3 Documents) B) HPT 052 English, Marathi and Hindi Informed consents and other documents for annual review and continuation of approval o. ame of the Document Version Date ARI-HPT English and Marathi Informed Consent Forms 1 Index &Partner Screening 2. Index Case Enrollment 3 Partner Enrollment English and Marathi) (2 Documents) 4 Index Case Pregnancy 5 Specimen Storage ARI-HPT Hindi Informed Consent Forms version 3.3 February 4, version 3.3 February 4, 6. Index Case and Partner Screening version 1.2 February 4, 7. Index Case Enrollment version 1.3 February 4, 8. Partner Enrollment version 1.3 February 4, 9. Index Case Pregnancy version 1.3 February 4, 10. Specimen Storage version 1.2 February 4, HPT Other Documents 11. Urug infont auon rampi,iei (ilindi) version i.d February 4, 26i0 12 Drug Information Pamphlet version 3.6 February 4, Page 3of 4 dryogcshnehctcla mail.com

4 Plot o. 73, `G' Block, MIDC, Bhosari, Pune l.net, S ammpune(dhotmai1.corn asim.human(a)gmail.com Sanlay.rutuj ana,gmai 1. com shrotriaparnala gmaii.com ikpal(aihotmail.com ni kakrani@hotmail.com Medicine --- mohangupted,yahoo.com rparaniapennariindia.org dryogeshnchctc(gmail.com 13. Flip Charts version 4.0 February 9, 14. Clinic cards for study participants A February 9, 15. HPT 052 Study update report A January 01, 2012 to December 31, 2012 C) HPT 052 study Pharmacy related documents for annual review and continuation of approval o. ame of the Document Version Date 1 HPTO52 label (Marathi & English) Drug Intake Calender (English, Marathi ) (2 Documents) 4 ' 0 3. Medicine Color code 1.0 4' Participant Information Material for January 16, Cap. Ritonavir (ORVIR)- (English, Marathi) 5. Participant Information Material for Tab. ovember 23, Ritonavir (orvir) - English and Marathi 1' Participant Information Material Version Date mentioned 6' (Contact Details for ARI Clinic is revised mentioned in the in the attached for all) attached list list This approval is valid for the period February 06, 2013 to February 05, Best Wishes Chairman, Ethics Committee, AM. Following member was given leave of absence : Mr. S. Jadhav, Adv. A. Sarode Mrs. Varsha Chinchkar as an alternate member was present. Page 4of 4

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