HIV Research

Find out more about our HIV research.

On this page

• Clinical Trials
• AHOD (HIV cohort study)
• MARCH (Maraviroc Switch study)
• Melbourne HIV Cohort
• STEAL (Switching antiretrovirals)

Clinical Trials

Completed

• BMS-790052 (Hepatitis C-HIV coinfection)
• Maraviroc Switch Collaborative Study (MARCH)
• STEAL (A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine)

Cohort studies

• Australian HIV Observational Database (AHOD)
• Melbourne HIV Cohort Study

Publications

Cryptococcemia in primary HIV infection.
Au Yeung V, Azzam R, Dendle C, Graham M, Woolley IJ, Korman TM.
Int J STD AIDS 2016 [in press]

Treatment and disease outcomes of migrants from low and middle income countries in the Australian HIV Observational Database (AHOD) cohort.

Tilley DM, Griggs E, Woolley I, Burke M, Hoy J, Wright ST, Catherine C O’Connor CC, on behalf of the Australian HIV Observational Database (AHOD).AIDS Care 2015 [in press].

Tenofovir therapy for Hepatitis B may be commonly prescribed without HIV testing.
Deshpande S, Ko T, Roberts E, Lau JS, Horne K, Williams J, Kiss C, Ratnam D, Woolley I.
J Acquir Immune Defic Syndr. 2015 Oct 20. [Epub ahead of print] No abstract available.
PMID: 26488453

A history of infection with varicella is strongly predictive of the presence of varicella-zoster virus antibodies in a heterogenous Australian HIV cohort.
Gurry GA, Dendle C, Korman TM, Giles ML, Williams JH, Woolley IJ.
AIDS. 2015 Sep 24;29(15):2062-2064. No abstract available.
PMID: 26352884

Factors associated with discussion of sexual activity and contraception in women with HIV.
Stewart ZA, Shipley K, Spelman T, Giles ML.
J Fam Plann Reprod Health Care. 2015 Apr 21. pii: jfprhc-2014-100937. doi: 10.1136/jfprhc-2014-100937. [Epub ahead of print]
PMID: 25900524

Temporal trends of time to antiretroviral treatment initiation, interruption and modification: examination of patients diagnosed with advanced HIV in Australia.

Wright ST, Law MG, Cooper DA, Keen P, McDonald A, Middleton M, Woolley I, Kelly M, Petoumenos K; Australian HIV Observational Database.
Int J AIDS Soc 2015 Apr 10;18(1):19463. doi: 10.7448/IAS.18.1.19463. eCollection 2015.
PMID: 25865372

Isn’t it time to talk about antiretroviral stewardship?
Woolley I.
J Chemother. 2015 Mar 24:1973947815Y0000000007. [Epub ahead of print] No abstract available.
PMID: 25800951

Latent infection in HIV-positive refugees and other immigrants in Australia.
Gurry GA, Dendle C, Woolley IJ.
Med J Aust. 2015 Mar 16;202(5):238-40.

Changes in the prevalence of lipodystrophy, metabolic syndrome   and cardiovascular disease risk in HIV-infected men.
Price J, Hoy J, Ridley E, Nyulasi I, Paul E, Woolley I.
Sex Health 2015 [In Press]  >http://dx.doi.org/10.1071/SH14084

Westhorpe CL, Schneider HG, Dunne M, Middleton T, Sundararajan V, Spelman T, Carter V, Crowe SM, Dart T, Mijch A, Kotsanas D, Woolley I.
Sex Health 2014 Dec;11(6):580-2. doi: 10.1071/SH14130.

Macrophage MIF (Migration Inhibitory Factor): a potential biomarker for cardiovascular disease in persons with HIV?
Woolley IJ, Ayoub S, Crowe SM, Westhorpe C, Cherry CL, Visvanathan K, Morand E.
AIDS. 2014 Jul 17;28(11):1693-4. doi: 10.1097/QAD.0000000000000276. No abstract available.
PMID: 25232902 [PubMed – in process]

Recent trends in response to combination antiretroviral therapy in Australia.
McManus H, Hoy JF, Woolley I, Boyd MA, Kelly MD, Mulhall B, Roth NJ, Petoumenos K, Law MG; the Australian HIV Observational Database.
Antivir Ther. 2014 Apr 4. doi: 10.3851/IMP2774. [Epub ahead of print]
PMID: 24704818 [PubMed – as supplied by publisher]

The significance of HIV ‘blips’ in resource-limited settings: is it the same? Analysis of the Treat Asia HIV Observational Database (TAHOD) and the Australian HIV Observational Database (AHOD).
Kanapathipillai R, McManus H, Kamarulzaman A, Lim PL, Templeton DJ, Law M, Woolley I.
PLoS One. 2014 Feb 7;9(2):e86122. doi: 10.1371/journal.pone.0086122. eCollection 2014.
PMID: 24516527 [PubMed – in process]

Determinants of Viraemia Copy-Years in People with HIV/AIDS Following Initiation of Antiretroviral Therapy.
Wright ST, Hoy J, Mulhall B, O’Connor CC, Petoumenos K, Read T, Smith D, Woolley I, Boyd MA; on behalf of the Australian HIV Observational Database.
J Acquir Immune Defic Syndr. 2014 May 1;66(1):55-64. doi: 10.1097/QAI.0000000000000125.
PMID: 24463783 [PubMed – indexed for MEDLINE]

The significance of low-level viremia in diverse settings: Analysis of the Treat Asia HIV Observational Database (TAHOD) and the Australian HIV Observational Database (AHOD).
Kanapathipillai R, McManus H, Giles ML, Ng OT, Cuoung DD, Nguyen K, Read T, Woolley I,
HIV Med. 2014 Aug;15(7):406-16. doi: 10.1111/hiv.12124. Epub 2014 Jan 26.
PMID: 24460817 [PubMed – in process]

Antiretroviral Treatment Interruption and Loss to Follow-up in Two HIV cohorts in Australia and Asia: Implications for ‘Test and Treat’ Prevention Strategy.
Guy R, Wand H, McManus H, Vonthanak S, Woolley I, Honda M, Read T, Sirisanthana T, Zhou J, Carr A. on behalf of AHOD and TAHOD.
AIDS Patient Care STDS. 2013 Dec;27(12):681-91. doi: 10.1089/apc.2012.0439.
PMID:24320013 [PubMed – in process]

The inside story. Physicians’ views on digital ano-rectal examination for anal cancer screening of HIV positive men who have sex with men.
Ong JJ, Chen M, Temple-Smith M, Walker S, Hoy J, Woolley I, Grulich AE, Fairley CK.
J Med Screen. 2013;20(4):188-91. doi: 10.1177/0969141313515463.
PMID:24307004 [PubMed – in process]

The two-edged sword: vasculitis associated with HIV and Hepatitis C coinfection.
Ojaimi S, Lin MW, Singh KP, Woolley I
Int J STD AIDS 2013 Jul 25. [Epub ahead of print]
PMID:23970639 [PubMed – as supplied by publisher]

HIV Replication Alters the Composition of Extrinsic Pathway Coagulation Factors and Increases Thrombin Generation
Baker JV, Brummel-Ziedins K, Neuhaus J, Duprez D, Cummins N, Dalmau D, DeHovitz J, Lehman C, Sullivan A, Woolley I, Kuller L, Neaton JD, Tracy RP. for the INSIGHT SMART Study Team.
J Am Heart Assoc 2013 Jul 29;2(4):e000264. doi: 10.1161/JAHA.113.000264.
PMID: 23896681 [PubMed – in process]

Human immunodeficiency virus and menopause.
Kanapathipillai R, Hickey M, Giles M.
Menopause. 2013 Mar 25. [Epub ahead of print]
PMID: 23531684 [PubMed – as supplied by publisher]

Cancer, immunodeficiency and antiretroviral treatment: results from the Australian HIV Observational Database (AHOD).
Petoumenos K, van Leuwen M , Vajdic C, Woolley I, Chuah J, Templeton DJ, Grulich A, Law M.
HIV Med. 2013 Feb;14(2):77-84. doi: 10.1111/j.1468-1293.2012.01038.x. Epub 2012 Aug 30.
PMID: 22934689 [PubMed – as supplied by publisher]

Inhibition of telomerase activity by HIV Nucleos(t)ide Reverse Transcriptase Inhibitors: a potential factor contributing to HIV-associated accelerated ageing.
Leeansyah E, Cameron PU, Solomon A, Tennakoon S, Velayudham P, Gouillou M, Spelman T, Hearps A, Fairley C, Smit DV, Pierce AB, Armishaw J, Crowe SM, Cooper DA, Koelsch KK, Liu JP, Chuah J, Lewin SR.
J Infect Dis. 2013 Jan 9. [Epub ahead of print]
PMID: 23303810 [PubMed – as supplied by publisher]

HIV and pregnancy – how to manage conflicting recommendations from evidence based guidelines.
Giles ML.
AIDS 2013;27(6):857-862, doi: 10.1097/QAD.0b013e32835ce308  Epub 2012 Nov 28. No abstract available
PMID:23196940 [PubMed – as supplied by publisher]

A qualitative study of HIV serodiscordant patients accessing assisted reproductive treatment.
Peak SA, Nowoweiski SJ, Giles ML.
J Reprod Infant Psych 2012;30(4):413-422.
DOI:10.1080/02646838.2012.733362

Differences in lipid measurements by antiretroviral regimen exposure in cohorts from Asia and australia.
Achhra AC, Amin J, Hoy J, Tanuma J, Sirisanthana T, Nolan D, Merati T, Giles M.
AIDS Res Treat. 2012;2012:246280. Epub 2012 May 14.
PMID: 22675613 [PubMed] Free PMC Article

Visiting friends and relatives may be a risk for non-adherence for HIV-positive travellers.
Woolley I, Bialy C.
Int J STD AIDS. 2012 Nov;23(11):833-4. doi: 10.1258/ijsa.2012.012063.
PMID: 23155108 [PubMed – in process]

Successful use of Eltrombopag without splenectomy in refractory HIV-related immune reconstitution thrombocytopenia.
Quach H. Lee LY. Smith B. Korman T. Woolley IJ.
AIDS. 2012 Sep 24;26(15):1977-9. No abstract available.
PMID: 22992580 [PubMed – in process]

Nonoccupational post-exposure prophylaxis source tracing: is it really feasible in Australia?
Pierce AB, Armishaw J, Price B, Wright EJ, Dax EM, Fairley CK, Hoy JF.
HIV Med. 2012 Aug;13(7):436-8. doi: 10.1111/j.1468-1293.2011.00986.x. Epub 2012 Jan 25.
PMID: 22276852 [PubMed – indexed for MEDLINE]

Adherence to HIV treatment guidelines for comorbid disease assessment and initiation of antiretroviral therapy.
Bloch M, Hoy J, Cunningham N, Roth N, Bailey M, Pierce A, Watson J, Carr A.
J Acquir Immune Defic Syndr. 2012 Apr 15;59(5):478-88.
PMID: 22367456 [PubMed – indexed for MEDLINE]

New HIV diagnosis after occupational exposure screening: the importance of reporting needlestick injuries.
Upjohn L. Stuart RL.  Korman TM. Woolley IJ.
Intern Med J. 2012 Feb;42(2):202-4. doi: 10.1111/j.1445-5994.2011.02616.x.
PMID: 22356494 [PubMed – in process]

Non-occupational post-exposure prophylaxis in Victoria, Australia: responding to high rates of re-presentation and low rates of follow-up.
Armishaw J, Hoy JF, Watson KM, Wright EJ, Price BG, Pierce AB.
Int J STD AIDS. 2011 Dec;22(12):714-8.
PMID: 22174051 [PubMed – indexed for MEDLINE]

Comment on: The DART Trial: ‘The Doctor’s Dilemma’ revisited.
Woolley I, Kanapathipillai R.
J Antimicrob Chemother. 2011 Sep;66(9):2192-3. Epub 2011 Jun 27.
PMID: 21712240 [PubMed – as supplied by publisher]

Rat Bite Fever as the presenting illness in a patient with AIDS.
Chean R, Stefanski DA, Woolley IJ, Francis MJ, Korman TM.
Infection. 2011 Jun;40(3):319-21. doi: 10.1007/s15010-011-0181-x. Epub 2011 Aug 30.
PMID:21877181 [PubMed – indexed for MEDLINE]

HIV seroconversions among male non-occupational post-exposure prophylaxis service users: a data linkage study.
Pierce AB, Yohannes K, Guy R, Watson KM, Armishaw J, Price B, Hoy JF, Wright EJ, Stoové MA.

Sex Health. 2011 Jun;8(2):179-83.
PMID: 21592431 [PubMed – in process]

Triple class experience after initiation of combination antiretroviral treatment in Australia: survival and projections.
Pour SM, Woolley I, Canavan P, Chuah J, Russell DB, Law M, Petoumenos, K.
Sex Health. 2011:8(3):295-303.

CD4 Cell Responses to Combination Antiretroviral Therapy in Patients Starting Therapy at High CD4 Cell Counts.
Wright ST, Carr A, Woolley I, Giles M, Hoy J, Cooper DA, Lawma MG; on behalf of the Australian HIV Observational Database..
J Acquir Immune Defic Syndr. 2011 Sep 1;58(1):72-9.

PMID: 21654498 [PubMed – as supplied by publisher]

Outcomes from the first assisted reproduction program for HIV-serodiscordant couples in Australia.
Giles ML, Barak S, Baker G, Perna S, Tabrizi S, Greengrass V, Bourne H, Clarke GN, Peak SA, Hoy JF, Foster P, Knight RL, On Behalf Of The CVI Study Group.
Med J Aust. 2011 Nov 21;195(10):599-601.
PMID: 22107010 [PubMed – in process]

Predictors and outcomes of HIV-infected antiretroviral-naive patients with discordant responses to combination antiretroviral treatment in Asian and Australian populations: results from APHOD.
Choi JY, Zhou J, Giles M, Broom J, Templeton DJ, Law MG, Chaiwarith R, Tanuma J; Asia-Pacific HIV Observational Database.
J Acquir Immune Defic Syndr. 2011 May 1;57(1):e13-5. No abstract available.
PMID: 21786460 [PubMed – in process]

Low CD4 Count is Associated with an Increased Risk of Fragility Fracture in HIV-infected Patients.
Yong MK, Elliott JH, Woolley IJ, Hoy JF.
J Acquir Immune Defic Syndr. 2011 Jul 1;57(3):205-10.
PMID: 21522014 [PubMed – as supplied by publisher]

The Clinical Significance of CD4 Counts in Asian and Caucasian HIV-Infected Popu
lations: Results from TAHOD and AHOD.
Achhra AC, Zhou J, Choi JY, Hoy J, Zhang F, Templeton DJ, Merati T, Woolley I, Petoumenos K, Amin J.
J Int Assoc Physicians AIDS Care (Chic). 2011 May-Jun;10(3):160-70. Epub 2011 Apr 20.
PMID: 21508296 [PubMed – as supplied by publisher]

Trends in detectable viral load by calendar year in the Australian HIV Observational Database.
Law MG, Woolley I, Templeton DJ, Roth N, Chuah J, Mulhall B, Canavan P, McManus H, Cooper DA, Petoumenos K, Database TA.
J Int AIDS Soc. 2011 Feb 23;14(1):10.
PMID: 21345234 [PubMed – – indexed for MEDLINE] Free Article

N-terminal-proB-type natriuretic peptide predicts cardiovascular disease events in HIV-infected patients.
Duprez DA, Neuhaus J, Tracy R, Kuller LH, Deeks SG, Orkin C, Stoehr A, Woolley IJ, Neaton JD; for the INSIGHT SMART Group.
AIDS. 2011 Mar 13;25(5):651-7.
PMID: 21245726 [PubMed – indexed for MEDLINE]

The Influence of Splenectomy on the Infectious Complications and Outcomes of people With HIV: Marked, Sustained Elevation in Risk of Severe Infection With Bacteria Including Streptococcus pneumoniae.
Polizzotto MN, Jones P, Cameron PU, Spelman D, Woolley IJ.
J Acquir Immune Defic Syndr. 2010 Nov 1;55(3):e24-e26. No abstract available.
PMID: 20948385 [PubMed – as supplied by publisher]

Abacavir does not affect circulating levels of inflammatory or coagulopathic biomarkers in suppressed HIV: a randomized clinical trial.
Martin A, Amin J, Cooper DA, Carr A, Kelleher AD, Bloch M, Baker D, Woolley I, Emery S; on behalf of the STEAL study group.
AIDS. 2010 Nov 13;24(17):2657-63.
PMID: 20827168 [PubMed – indexed for MEDLINE]

Autoimmune haemolytic anaemia: an unusual presentation of HIV seroconversion disease.
Sherry NL, Woolley IJ, Korman TM.
AIDS. 2010 Jul 31;24(12):1968-70. No abstract available.
PMID: 20622531 [PubMed – in process]

The “work” of women when considering and using interventions to reduce mother-to-child transmission (MTCT) of HIV.
Giles ML, Hellard ME, Lewin SR, O’Brien ML.
AIDS Care. 2009 Oct;21(10):1230-7.
PMID: 20024698 [PubMed – indexed for MEDLINE]

Cost-effectiveness of HIV nonoccupational post-exposure prophylaxis in Australia.
Guinot D, Ho MT, Poynten IM, McAllister J, Pierce A, Pell C, Grulich AE.
HIV Med. 2009 Apr;10(4):199-208. Epub 2009 Jan 22.

Perinatal exposure to HIV among children born in Australia, 1982-2006.
McDonald AM, Zurynski YA, Wand HC, Giles ML, Elliott EJ, Ziegler JB, Kaldor JM.
Med J Aust. 2009 Apr 20;190(8):416-20.
PMID: 19374612 [PubMed – indexed for MEDLINE]

Antenatal screening practice for infectious diseases by general practitioners in Australia.
Giles ML, Pedrana A, Jones C, Garland S, Hellard M, Lewin SR.
Aust N Z J Obstet Gynaecol. 2009 Feb;49(1):39-44.
PMID: 19281578 [PubMed – indexed for MEDLINE]

HIV and pregnancy: screening and management update.
Giles M.
Curr Opin Obstet Gynecol. 2009 Apr;21(2):131-5. Review.
PMID: 19276805 [PubMed – indexed for MEDLINE]

African Australians living with HIV: a case series from Victoria.
Lemoh CN, Baho S, Grierson J, Hellard M, Street A, Biggs BA.
Sex Health. 2010 Jun;7(2):142-8.
PMID: 20465977 [PubMed – in process]

Delayed diagnosis of HIV infection in Victoria 1994 to 2006.
Lemoh C, Guy R, Yohannes K, Lewis J, Street A, Biggs B, Hellard M.
Sex Health. 2009 Jun;6(2):117-22.
PMID: 19457290 [PubMed – indexed for MEDLINE]

Sudanese women living in Victoria, Australia: health-information-seeking behaviours and the availability, effectiveness and appropriateness of HIV/AIDS information
Palmer R, Lemoh C, Tham R, Hakim S, Biggs BA.
Diversity Health Social Care. 2009;6(2):109-20.

Working with West African migrant communities on HIV prevention in Australia.
Lemoh C, Biggs BA, Hellard M.
Sex Health. 2008 Dec;5(4):313-4. No abstract available.
PMID: 19189498 [PubMed – indexed for MEDLINE]

Unrecognised vitamin D deficiency: low concentrations in African migrants with HIV in Australia.
Woolley IJ, Giles ML, Howard JE, Korman TM.
Sex Health. 2008 Dec;5(4):375-6. No abstract available.
PMID: 19189504 [PubMed – indexed for MEDLINE]

HIV transmission: the ongoing importance of antenatal screening.
Upjohn LM, Korman TM, Giles ML.
N Z Med J. 2008 Sep 5;121(1281):94-5. No abstract available.
PMID: 18797491 [PubMed – indexed for MEDLINE]

HIV infection and high density lipoprotein metabolism.
Rose H, Hoy J, Woolley I, Tchoua U, Bukrinsky M, Dart A, Sviridov D.
Atherosclerosis. 2008 Jul;199(1):79-86. Epub 2007 Dec 4.
PMID: 18054941 [PubMed – indexed for MEDLINE]Free PMC ArticleFree text

Variable uptake of recommended interventions to reduce mother-to-child transmission of HIV in Australia, 1982-2005.
Giles ML, McDonald AM, Elliott EJ, Ziegler JB, Hellard ME, Lewin SR, Kaldor JM.
Med J Aust. 2008 Aug 4;189(3):151-4.

PMID: 18673102 [PubMed – indexed for MEDLINE]Free Article

What are the barriers to offering HIV testing in an antenatal setting? A national study of obstetricians.
Giles ML, Garland SM, Lewin SR, Hellard ME.
AIDS. 2007 Jul 31;21(12):1601-6.
PMID: 17630555 [PubMed – indexed for MEDLINE]

Cambodian-born individuals diagnosed with HIV in Victoria: epidemiological findings and health service implications.
Ayton DR, Guy RJ, Woolley IJ, Hellard ME.
Sex Health. 2007 Sep;4(3):209. No abstract available.
PMID: 17969939 [PubMed – indexed for MEDLINE]

Prevalence of and risk factors for HIV-associated neuropathy in Melbourne, Australia 1993-2006.
Smyth K, Affandi JS, McArthur JC, Bowtell-Harris C, Mijch AM, Watson K, Costello K, Woolley IJ, Price P, Wesselingh SL, Cherry CL.
HIV Med. 2007 Sep;8(6):367-73.
PMID: 17661844 [PubMed – indexed for MEDLINE]

Statins Blunt HAART-Induced CD4 T-Cell Gains but Have No Long-Term Effect on Virologic Response to HAART.
Rodriguez B, Valdez H, Mijch A, Watson K
, Lederman MM, McComsey GA, Loupa CV, Woolley I.
J Int Assoc Physicians AIDS Care (Chic Ill). 2007 Sep;6(3):198-202. Epub 2007 Jun 19.
PMID: 17579125 [PubMed – in process]

Macrolide use and the risk of vascular disease in HIV-infected men in the Multicenter AIDS Cohort Study.
Woolley IJ, Li X, Jacobson LP, Palella FJ, Ostergaard L.
Sex Health. 2007 Jun;4(2):111-9.
PMID: 17524289 [PubMed – indexed for MEDLINE]

Acute pancreatitis caused by tipranavir/ritonavir-induced hypertriglyceridaemia.
Chapman SJ, Woolley IJ, Visvanathan K, Korman TM.
AIDS. 2007 Feb 19;21(4):532-3. No abstract available.
PMID: 17301578 [PubMed – indexed for MEDLINE]

Occupational exposures experienced by medical students during overseas electives.
Smith P, Drummond C, Woolley I.
Aust Infect Control. 2006;11(4): 123 – 133.

A randomised controlled trial of omega-3 fatty acid supplementation for the treatment of hypertriglyceridemia in HIV-infected males on highly active antiretroviral therapy.
Carter VM, Woolley I, Jolley D, Nyulasi I, Mijch A, Dart A.
Sex Health. 2006 Dec;3(4):287-90.
PMID: 17112442 [PubMed – indexed for MEDLINE]

Exogenous glucocorticoid excess as a result of ritonavir-fluticasone interaction.
Soldatos G, Sztal-Mazer S, Woolley I, Stockigt J.
Intern Med J. 2005 Jan;35(1):67-8. No abstract available.
PMID: 15667475 [PubMed – indexed for MEDLINE]

Eosinophilic folliculitis: an example of ‘immune reconstitution folliculitis’?
Moyle M, Woolley IJ, Thevarajan I, Korman TM.
AIDS. 2004 Nov 19;18(17):2350-2. No abstract available.
PMID: 15577558 [PubMed – indexed for MEDLINE]

Fragility fractures in HIV-infected patients: need for better understanding of diagnosis and management.
McComsey GA, Huang JS, Woolley IJ, Young B, Sax PE, Gerber M, Swindells S, Bonilla H, Gopalakrishnan G.
J Int Assoc Physicians AIDS Care (Chic Ill). 2004 Jul-Sep;3(3):86-91.
PMID: 15573712 [PubMed – indexed for MEDLINE]

Chlamydia pneumoniae in HIV-infected patients and controls assessed by a novel whole blood interferon-gamma assay, serology and PCR.
Woolley IJ, Larsen M, Jones S, Gahan ME, Jasenko I, Johnsen SP, Wesselingh S, Fuller A, Ostergaard L.
Clin Microbiol Infect. 2004 Sep;10(9):820-5.
PMID: 15355413 [PubMed – indexed for MEDLINE]

Lichenoid drug eruption to tenofovir in an HIV/hepatitis B virus co-infected patient.
Woolley IJ, Veitch AJ, Harangozo CS, Moyle M, Korman TM.
AIDS. 2004 Sep 3;18(13):1857-8. No abstract available.
PMID: 15316351 [PubMed – indexed for MEDLINE]

Disseminated mycobacterium avium-intracellulare complex (MAC) infection in the era of effective antiretroviral therapy: is prophylaxis still indicated?
Lange CG, Woolley IJ, Brodt RH.
Drugs. 2004;64(7):679-92. Review.
PMID: 15025543 [PubMed – indexed for MEDLINE]

Anterior neck fat deposition in lipodystrophy syndrome; a new variant on a theme?
Woolley IJ, Mijch AM, Carter VM, Archer B, Hoy JF.
AIDS. 2003 Aug 15;17(12):1857-8. No abstract available.
PMID: 12891075 [PubMed – indexed for MEDLINE]

Back to top

AHOD (HIV cohort study)

Back to top

MARCH (Maraviroc Switch Study)

Maraviroc Switch Collaborative Study

clinicaltrials.gov

Summary

MARCH is an international, multicentre trial planning to enroll HIV-1 infected patients who are currently  virologically suppressed. Participants will be randomized (1:2:2) to one of three treatment groups

1. to continue their current treatment regimen
2. maraviroc dose at 150 mg twice daily with PI/r, or
3. maraviroc at 300 mg twice daily with 2N(t)RTI.

Aims

To investigate whether switching to maraviroc, in combination with either RTI or PI/r,

• is as good at keeping the HIV viral load undetectable as the combination of RTI with PI/r
• will improve some of the side effects that can be seen when people take combination therapy including RTI and PI/r.

The study hypothesis is that in stable, virologically suppressed (plasma HIV-RNA <200 copies=”” ml=”” patients=”” with=”” no=”” history=”” of=”” prior=”” virological=”” failure=”” a=”” switch=”” to=”” either=”” mvc=”” dosed=”” at=”” 300mg=”” twice=”” daily=”” bid=”” combined=”” the=”” same=”” 2n=”” t=”” rti=”” backbone=”” regimen=”” or=”” 150mg=”” current=”” pi=”” r=”” discretion=”” investigator=”” if=”” is=”” fosamprenavir=”” provides=”” similar=”” non-inferior=”” antiretroviral=”” efficacy=”” compared=”” continuation=”” br=””>

Primary Outcome Measures

The comparison of the switch arms to control arm of proportions of participants with HIV RNA <200 copies=”” ml=”” 48=”” weeks=”” after=”” randomisation=”” br=””>

Secondary Outcome Measures

• Virological endpoints: proportion of participants with plasma HIV-1 RNA<50 copies=”” ml=”” time=”” frame:=”” 48=”” weeks=”” from=”” randomization=”” li=””>
• Immunologic and biomarkers
• Clinical
• Metabolic and body composition
• Safety
• Adherence
• Quality of Life
• Resistance endpoints

Back to top

Melbourne HIV Cohort

Background and Rationale

Despite a dramatic improvement in life expectancy in patients living with HIV since the introduction of antiretroviral therapy there is still a significant gap compared with the general population. In Australia the majority of morbidity and mortality in the HIV positive population does not result from infectious complications but from chronic conditions such as cardiovascular disease, liver and renal disease. It is likely that these conditions result from a combination of the HIV infection itself, anti-retroviral toxicity, health behaviours and underlying risks.
The aim of this study is to establish a multi-centre cohort of HIV positive and HIV negative patients as a basis for further research into these chronic conditions that now significantly affect the lives of people living with HIV.

Objectives

1. Establish and follow a cohort of HIV treatment naïve patients with HIV negative controls, in order perform and facilitate a wide range of high quality research projects of relevance to people living with HIV.
2. To create a partnership and infrastructure that encourages high quality collaborative HIV basic, clinical and behavioural science research.

Patient Population

The study will enrol 100 HIV positive cases and 100 HIV negative controls over a 2 year period
1. Inclusion criteria for HIV positive cases are:
a) Less than 7 days of prior HIV antiretroviral treatment since HIV diagnosis and less than 1 month of anti-retroviral exposure for post-exposure prophylaxis in the year prior to enrolment if they had a negative HIV test following anti-virals.
b) Age ≥ 18 years old
c) Regularly attending and likely to continue in follow up
d) Willing and able to provide written informed consent

2. Inclusion criteria for HIV negative control group are:
a) Male
b) Identify as having male sexual partners
c) Negative HIV test within past 12 months
d) Less than 1 month of anti-retoviral exposure in form of post-exposure prophylaxis (PEP) in the year prior to enrolment. Patients that have had PEP must have a negative HIV test after completing the anti-retroviral course.
e) Age ≥ 18 years old
f) Regularly attending and likely to continue in follow up
g) Willing and able to provide written informed consent

Study Design

Prospective observational cohort study.
Patients will have major clinical visits annually which will include:
a. Clinical history of demographic and socioeconomic details, past medical history, major clinical events and medications
b. Collection of investigation results performed as routine clinical care
c. Completion of confidential questionnaires about mental health, drug and alcohol use, quality of life and sexual satisfaction
d. Height, weight and blood pressure measurements
e. Collection of blood for storage

At baseline and every 2nd annual visit this will also include:
a. Carotid intimal medial thickening assessment (cIMT)
b. Electrocardiogram (ECG)
c. DEXA bone scan
d. Neurocognitive screening

At six month intervals there will be a brief visit or telephone consult to review major clinical events, hospitalisations, and change to medications.
In the HIV positive group there will also be visits at 3 and 6 months after antiretroviral therapy is commenced. This will involve collection of clinical and laboratory results as for the annual visit but will not involve questionnaires or additional investigations.

Participating Sites

• Alfred Hospital
• Centre Clinic
• Melbourne Sexual Health Centre
• Monash Infectious Diseases
• Northside Clinic
• Prahran Market Clinic

Back to top

STEAL (Switching antiretrovirals)

A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study

This study has been completed.

Detailed Description

The aim of this study is to compare the overall safety and efficacy of two dual-NRTI, once daily, tablets over a 2 year period in HIV infected adults.
The study is a randomised, multi-centre, 2 year study of two dual NRTI, once daily tablets in subjects with HIV, currently taking two individual NRTIs as part of their therapy. 350 subjects will be randomised in a 1:1 ratio to either:
1. tenofovir (TDF) 300mg + emtricitabine (FTC) 200mg OR
2. abacavir (ABC) 600mg + lamivudine (3TC) 300mg. Subjects will cease their current individual NRTI treatment, commence their randomised dual NRTI tablet, and continue on their current NNRTI or PI therapy.

Primary Outcome Measures

• virological failure defined by HIV RNA>400copies/mL plasma on 2 consecutive occasions ³4 wks apart

Secondary Outcome Measures

• plasma HIV RNA<50copies/mL; time to virological failure (VF); virological resistance in those with VF; all SAEs; use of concomitant meds for toxicity; adherence; QoL; CD4+lymphocyte count; full blood count; biochemistry; lipid parameters [ Time Frame: Week 48 and 96 ]

• glycaemic parameters; DEXA parameters; resolution of AEs; progression to AIDS; death; discontinuation of ART [ Time Frame: Week 48 and 96 ]

Publications

The influence of HLA supertype on thymidine analogue associated with low peripheral fat in HIV.
Cordery DV, Martin A, Amin J, Kelleher AD, Emery S, Cooper DA; STEAL study group.
AIDS. 2012 Nov 28;26(18):2337-44. doi: 10.1097/QAD.0b013e32835ab213.
PMID: 23032422 [PubMed – in process]

Changes in bone turnover and bone loss in HIV-infected patients changing treatment to tenofovir-emtricitabine or abacavir-lamivudine.
Haskelberg H, Hoy JF, Amin J, Ebeling PR, Emery S, Carr A, STEAL Study Group.
PLoS One. 2012;7(6):e38377. doi: 10.1371/journal.pone.0038377. Epub 2012 Jun 15.
PMID: 22719882 [PubMed – indexed for MEDLINE] Free PMC Article

Predictors of Limb Fat Gain in HIV Positive Patients Following a Change to Tenofovir-Emtricitabine or Abacavir-Lamivudine.
Martin A, Amin J, Emery S, Baker D, Carr A, Cooper DA, Bloch M.
PLoS One. 2011;6(10):e26885. Epub 2011 Oct 28.
PMID: 22046394 [PubMed – as supplied by publisher]

Abacavir does not affect circulating levels of inflammatory or coagulopathic biomarkers in suppressed HIV: a randomized clinical trial.
Martin A, Amin J, Cooper DA, Carr A, Kelleher AD, Bloch M, Baker D, Woolley I, Emery S; STEAL study group.
AIDS. 2010 Nov 13;24(17):2657-63.

Back to top