Alcohol Drinkers’ Exposure to Preventive Therapy for TB (ADEPTT)

Overview

The Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT) will examine the safety and tolerability of, and adherence to, 6 months of daily INH (6H) in 300 TB and HIV-infected persons (200 drinkers and 100 non-drinkers) in Uganda. The first aim is to evaluate the safety and tolerability of 6H overall and by level of alcohol use. The second aim is to estimate adherence and compare adherence by level of alcohol use and at 3 and 6 months. Self-reported measures of alcohol use will be augmented by phosphatidylethanol (PEth), an established biomarker of alcohol use. Objective measures of adherence will include electronic pill bottle monitoring and a novel measure of INH exposure, INH concentration in hair. The study will actively monitor for hepatotoxicity using the U.S. standard of care for TB preventive therapy for heavy drinkers and discontinue if any Grade 3/4 toxicities are detected. The investigators will use the safety, tolerability, and adherence results, together with the known efficacy and mortality benefit of TB preventive therapy in HIV-infected persons in SSA, and an established decision analytic model of TB preventive therapy to conduct the third aim: to determine whether the benefits of TB preventive therapy outweigh the toxicity risks for HIV-infected drinkers in resource limited settings. The study will additionally follow the cohort every 6 months after completing INH to monitor drinking and the development of active TB.

Full Title of Study: “URBAN ARCH (3/5) Uganda Cohort TB Preventive Therapy for HIV-infected Alcohol Users in Uganda: an Evaluation of Safety Tolerability and Adherence”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 1, 2021

Detailed Description

Tuberculosis (TB) is the leading cause of mortality in persons with HIV worldwide, accounting for 20-33% of HIV-related deaths, and is a high-priority area of research in HIV/AIDS by the NIH. TB preventive therapy decreases both all-cause mortality and active TB in persons with HIV by 30-50% above and beyond the benefits of antiretroviral therapy (ART) alone. Based on these findings, the World Health Organization (WHO) recommends isoniazid (INH) preventive therapy (IPT) for all persons with HIV in resource constrained settings. However, the WHO warns against the use of IPT in persons with "regular and heavy alcohol use." This exclusion stems from concern for increased hepatotoxicity in heavy drinkers in settings where liver enzymes are not routinely monitored. Heavy drinking in persons with HIV is very common, approximately 25%, in sub-Saharan Africa (SSA). Heavy drinking increases the risk for active TB at least threefold; thus, HIV-infected alcohol users should be prioritized for TB prevention. However, no studies have systematically assessed the safety of TB preventive therapy in heavy drinkers with or without HIV infection. It is critical to examine the safety and tolerability of TB preventive therapy for HIV-infected drinkers, given the high rates of HIV, TB infection, and alcohol comorbidities worldwide. While the risk of toxicity exists, the risk of TB disease could outweigh the toxicity harms. Thus, it is also crucial to determine whether the mortality benefits outweigh the toxicity risks for this significant portion of the HIV-infected population. In addition, TB preventive therapy is only effective if taken consistently for the full course. Alcohol use is an established risk factor for decreased ART pill taking and active TB treatment discontinuation. Whether HIV-infected drinkers on ART can be adherent to TB preventive therapy is not known. Therefore it is essential to determine the level of adherence to TB preventive therapy by HIV-infected drinkers on ART, thus this study aims to examine adherence to TB preventative therapy as well. This is a study to examine 6 months of daily INH (6H) among N=300 persons co-infected with HIV and TB. The aims of the study are: Aim 1: To examine the safety and tolerability of 6H in HIV/TB co-infected drinkers, measured by hepatotoxicity and treatment discontinuation rates. The main aim is to estimate safety and tolerability overall among drinkers (primary) and by level of drinking (secondary). Aim 2: To determine the level of TB preventive therapy adherence overall among drinkers and by level of drinking, and at 3 and 6 months. The main goal of this aim is to estimate adherence overall among drinkers (primary). Secondarily the investigators will estimate adherence by level of drinking (heavy, current but not heavy drinkers, and non-drinkers) and compare adherence across drinking levels. The investigators hypothesize that adherence will be highest among the non-drinkers. Aim 3: To determine whether the benefits of providing TB preventive therapy to HIV-infected drinkers in resource-limited settings outweigh the risks compared to no treatment. The investigators hypothesize that providing TB preventive therapy will result in longer life expectancy and quality-adjusted life expectancy than not providing TB preventive therapy (current standard of care).

Interventions

  • Drug: Isoniazid 300 Mg ORAL TABLET
    • The study intervention will include a single arm given (1) 6H: 300 mg INH daily by mouth for 6 months.
  • Drug: Pyridoxine 25 Mg Oral Tablet
    • All participants will also receive 25 mg pyridoxine (vitamin B-6) daily by mouth for 6 months for the treatment duration to reduce the risk of INH-induced peripheral neuropathy.

Arms, Groups and Cohorts

  • Experimental: Isoniazid & pyridoxine
    • Isoniazid 300 mg oral tablet: 300 mg daily by mouth for 6 months. Pyridoxine 25 mg oral tablet: 25mg daily by mouth for 6 months.

Clinical Trial Outcome Measures

Primary Measures

  • Cumulative Incidence of Participants Experiencing a Grade 3/4 Hepatotoxicity
    • Time Frame: Hepatotoxicity occurring during the six month course (180 pills) of isoniazid (INH), which may be taken over a maximum of 9 months.
    • Safety will be assessed by the occurrence of a Grade 3/4 hepatotoxicity at any time during the assigned treatment period.

Secondary Measures

  • Number of Participants Who Discontinued Treatment
    • Time Frame: Six month course (180 pills) of isoniazid (INH), which may be taken over a maximum of 9 months.
    • Lack of tolerability will be defined as any isoniazid (INH) treatment discontinuation prior to completion of the prescribed course (6 months of INH taken over a maximum period of 9 months) due to side effects or alanine transaminase (ALT)/aspartate transaminase (AST) elevations.
  • Percentage of Participants With Suboptimal INH Medication Adherence
    • Time Frame: Adherence will be measured over the 6 months on INH or until INH discontinuation (whichever is shorter)
    • Suboptimal INH adherence was defined as <90% of days with at least 1 electronic medication management (EMM) pill cap opening in the previous 90 days, at 3- and 6-months.
  • Self-reported INH Medication Adherence: Number of Days Taking INH in the Past 30 Days
    • Time Frame: Self-reported INH medication adherence via VAS will be measured 3- and 6- months after starting INH
    • Participants were asked “In the past 30 days, how many days in total have you not taken your pill?” and were presented with a visual analog scale (VAS) to indicate the percentage of INH taken in the past 30 days. We converted the VAS percentage into number of days out of 30 to match the first question. Our final self-report measure was the minimum number of the 2 self-reported measurements.
  • Self-reported INH Medication Adherence by the Self Rating Single Item (SRSI) Scale
    • Time Frame: Self-reported INH medication adherence via SRSI will be measured 3- and 6- months after starting INH
    • The Self Rating Single Item (SRSI) adherence scale asks participants to rate their ability to take their medications as prescribed over the past 30 days. Participants reporting INH use in the prior 30 days at the 3- or 6-month interview are included here, and reported their INH adherence in the prior 30 days as excellent, very good, good, fair, poor, or very poor.

Participating in This Clinical Trial

Inclusion Criteria

1. Age > 18 years old 2. Patient of the MRRH ISS Clinic 3. HIV-infected 4. Consume alcohol (self-reported consumption in the prior 3 months) (2/3) OR prior year non-drinker (1/3) 5. Live within 2 hours of travel time to the ISS Clinic 6. Fluent in either Runyankole or English 7. No ALT/AST elevations (< = 2X ULN) confirmed by testing 8. On ART for at least 6 months 9. No history of active TB, TB treatment, or TB preventive therapy 10. No probable current active TB as determined by symptom screening and followed by chest X-ray and Xpert MTB/RIF (if symptomatic) 11. Positive TST results confirmed by testing Exclusion Criteria:

1. Plans to move out of the catchment area within 6 months 2. Probable TB via symptom screen and subsequent assessments 3. History or current or past active TB, TB treatment, or TB preventive therapy 4. ALT or AST >2x ULN 5. Pregnant women

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, San Francisco
  • Collaborator
    • Boston University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Judith A Hahn, PhD, MA, Principal Investigator, University of California, San Francisco

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Baxi SM, Greenblatt RM, Bacchetti P, Jin C, French AL, Keller MJ, Augenbraun MH, Gange SJ, Liu C, Mack WJ, Gandhi M; Women's Interagency HIV Study (WIHS). Nevirapine Concentration in Hair Samples Is a Strong Predictor of Virologic Suppression in a Prospective Cohort of HIV-Infected Patients. PLoS One. 2015 Jun 8;10(6):e0129100. doi: 10.1371/journal.pone.0129100. eCollection 2015.

Koss CA, Natureeba P, Mwesigwa J, Cohan D, Nzarubara B, Bacchetti P, Horng H, Clark TD, Plenty A, Ruel TD, Achan J, Charlebois ED, Kamya MR, Havlir DV, Gandhi M. Hair concentrations of antiretrovirals predict viral suppression in HIV-infected pregnant and breastfeeding Ugandan women. AIDS. 2015 Apr 24;29(7):825-30. doi: 10.1097/QAD.0000000000000619. Erratum In: AIDS. 2015 Nov;29(17):2369.

Prasitsuebsai W, Kerr SJ, Truong KH, Ananworanich J, Do VC, Nguyen LV, Kurniati N, Kosalaraksa P, Sudjaritruk T, Chokephaibulkit K, Thammajaruk N, Singtoroj T, Teeraananchai S, Horng H, Bacchetti P, Gandhi M, Sohn AH. Using Lopinavir Concentrations in Hair Samples to Assess Treatment Outcomes on Second-Line Regimens Among Asian Children. AIDS Res Hum Retroviruses. 2015 Oct;31(10):1009-14. doi: 10.1089/AID.2015.0111. Epub 2015 Aug 26.

Huang Y, Gandhi M, Greenblatt RM, Gee W, Lin ET, Messenkoff N. Sensitive analysis of anti-HIV drugs, efavirenz, lopinavir and ritonavir, in human hair by liquid chromatography coupled with tandem mass spectrometry. Rapid Commun Mass Spectrom. 2008 Nov;22(21):3401-9. doi: 10.1002/rcm.3750.

Huang Y, Yang Q, Yoon K, Lei Y, Shi R, Gee W, Lin ET, Greenblatt RM, Gandhi M. Microanalysis of the antiretroviral nevirapine in human hair from HIV-infected patients by liquid chromatography-tandem mass spectrometry. Anal Bioanal Chem. 2011 Oct;401(6):1923-33. doi: 10.1007/s00216-011-5278-7. Epub 2011 Aug 17.

Hickey MD, Salmen CR, Tessler RA, Omollo D, Bacchetti P, Magerenge R, Mattah B, Salmen MR, Zoughbie D, Fiorella KJ, Geng E, Njoroge B, Jin C, Huang Y, Bukusi EA, Cohen CR, Gandhi M. Antiretroviral concentrations in small hair samples as a feasible marker of adherence in rural Kenya. J Acquir Immune Defic Syndr. 2014 Jul 1;66(3):311-5. doi: 10.1097/QAI.0000000000000154. Erratum In: J Acquir Immune Defic Syndr. 2015 May 1;69(1):e42.

Gandhi M, Mwesigwa J, Aweeka F, Plenty A, Charlebois E, Ruel TD, Huang Y, Clark T, Ades V, Natureeba P, Luwedde FA, Achan J, Kamya MR, Havlir DV, Cohan D; Prevention of Malaria and HIV disease in Tororo (PROMOTE) study. Hair and plasma data show that lopinavir, ritonavir, and efavirenz all transfer from mother to infant in utero, but only efavirenz transfers via breastfeeding. J Acquir Immune Defic Syndr. 2013 Aug 15;63(5):578-84. doi: 10.1097/QAI.0b013e31829c48ad.

Baxi SM, Liu A, Bacchetti P, Mutua G, Sanders EJ, Kibengo FM, Haberer JE, Rooney J, Hendrix CW, Anderson PL, Huang Y, Priddy F, Gandhi M. Comparing the novel method of assessing PrEP adherence/exposure using hair samples to other pharmacologic and traditional measures. J Acquir Immune Defic Syndr. 2015 Jan 1;68(1):13-20. doi: 10.1097/QAI.0000000000000386.

Cohan D, Natureeba P, Koss CA, Plenty A, Luwedde F, Mwesigwa J, Ades V, Charlebois ED, Gandhi M, Clark TD, Nzarubara B, Achan J, Ruel T, Kamya MR, Havlir DV. Efficacy and safety of lopinavir/ritonavir versus efavirenz-based antiretroviral therapy in HIV-infected pregnant Ugandan women. AIDS. 2015 Jan 14;29(2):183-91. doi: 10.1097/QAD.0000000000000531.

Hahn JA, Emenyonu NI, Fatch R, Muyindike WR, Kekiibina A, Carrico AW, Woolf-King S, Shiboski S. Declining and rebounding unhealthy alcohol consumption during the first year of HIV care in rural Uganda, using phosphatidylethanol to augment self-report. Addiction. 2016 Feb;111(2):272-9. doi: 10.1111/add.13173. Epub 2015 Nov 5.

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Sharma SK, Sharma A, Kadhiravan T, Tharyan P. Rifamycins (rifampicin, rifabutin and rifapentine) compared to isoniazid for preventing tuberculosis in HIV-negative people at risk of active TB. Cochrane Database Syst Rev. 2013 Jul 5;2013(7):CD007545. doi: 10.1002/14651858.CD007545.pub2.

Johnson JL, Okwera A, Hom DL, Mayanja H, Mutuluuza Kityo C, Nsubuga P, Nakibali JG, Loughlin AM, Yun H, Mugyenyi PN, Vernon A, Mugerwa RD, Ellner JJ, Whalen CC; Uganda-Case Western Reserve University Research Collaboration. Duration of efficacy of treatment of latent tuberculosis infection in HIV-infected adults. AIDS. 2001 Nov 9;15(16):2137-47. doi: 10.1097/00002030-200111090-00009.

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Gupta S, Abimbola T, Date A, Suthar AB, Bennett R, Sangrujee N, Granich R. Cost-effectiveness of the Three I's for HIV/TB and ART to prevent TB among people living with HIV. Int J Tuberc Lung Dis. 2014 Oct;18(10):1159-65. doi: 10.5588/ijtld.13.0571.

Pho MT, Swaminathan S, Kumarasamy N, Losina E, Ponnuraja C, Uhler LM, Scott CA, Mayer KH, Freedberg KA, Walensky RP. The cost-effectiveness of tuberculosis preventive therapy for HIV-infected individuals in southern India: a trial-based analysis. PLoS One. 2012;7(4):e36001. doi: 10.1371/journal.pone.0036001. Epub 2012 Apr 30.

Smith T, Samandari T, Abimbola T, Marston B, Sangrujee N. Implementation and Operational Research: Cost-Effectiveness of Antiretroviral Therapy and Isoniazid Prophylaxis to Reduce Tuberculosis and Death in People Living With HIV in Botswana. J Acquir Immune Defic Syndr. 2015 Nov 1;70(3):e84-93. doi: 10.1097/QAI.0000000000000783.

Hahn JA, Fatch R, Kabami J, Mayanja B, Emenyonu NI, Martin J, Bangsberg DR. Self-Report of Alcohol Use Increases When Specimens for Alcohol Biomarkers Are Collected in Persons With HIV in Uganda. J Acquir Immune Defic Syndr. 2012 Dec 1;61(4):e63-4. doi: 10.1097/QAI.0b013e318267c0f1. No abstract available.

Getahun H, Matteelli A, Abubakar I, Aziz MA, Baddeley A, Barreira D, Den Boon S, Borroto Gutierrez SM, Bruchfeld J, Burhan E, Cavalcante S, Cedillos R, Chaisson R, Chee CB, Chesire L, Corbett E, Dara M, Denholm J, de Vries G, Falzon D, Ford N, Gale-Rowe M, Gilpin C, Girardi E, Go UY, Govindasamy D, D Grant A, Grzemska M, Harris R, Horsburgh CR Jr, Ismayilov A, Jaramillo E, Kik S, Kranzer K, Lienhardt C, LoBue P, Lonnroth K, Marks G, Menzies D, Migliori GB, Mosca D, Mukadi YD, Mwinga A, Nelson L, Nishikiori N, Oordt-Speets A, Rangaka MX, Reis A, Rotz L, Sandgren A, Sane Schepisi M, Schunemann HJ, Sharma SK, Sotgiu G, Stagg HR, Sterling TR, Tayeb T, Uplekar M, van der Werf MJ, Vandevelde W, van Kessel F, van't Hoog A, Varma JK, Vezhnina N, Voniatis C, Vonk Noordegraaf-Schouten M, Weil D, Weyer K, Wilkinson RJ, Yoshiyama T, Zellweger JP, Raviglione M. Management of latent Mycobacterium tuberculosis infection: WHO guidelines for low tuberculosis burden countries. Eur Respir J. 2015 Dec;46(6):1563-76. doi: 10.1183/13993003.01245-2015. Epub 2015 Sep 24.

Gupta RK, Lucas SB, Fielding KL, Lawn SD. Prevalence of tuberculosis in post-mortem studies of HIV-infected adults and children in resource-limited settings: a systematic review and meta-analysis. AIDS. 2015 Sep 24;29(15):1987-2002. doi: 10.1097/QAD.0000000000000802.

Eby J, Chapman J, Marukutira T, Anabwani G, Tshume O, Lepodisi O, Dipotso T, Mokete K, Gross R, Lowenthal E. The adherence-outcome relationship is not altered by diary-driven adjustments of microelectronic monitor data. Pharmacoepidemiol Drug Saf. 2015 Dec;24(12):1313-20. doi: 10.1002/pds.3887. Epub 2015 Oct 12.

Berg KM, Arnsten JH. Practical and conceptual challenges in measuring antiretroviral adherence. J Acquir Immune Defic Syndr. 2006 Dec 1;43 Suppl 1(Suppl 1):S79-87. doi: 10.1097/01.qai.0000248337.97814.66.

Winhusen TM, Kropp F, Lindblad R, Douaihy A, Haynes L, Hodgkins C, Chartier K, Kampman KM, Sharma G, Lewis DF, VanVeldhuisen P, Theobald J, May J, Brigham GS. Multisite, randomized, double-blind, placebo-controlled pilot clinical trial to evaluate the efficacy of buspirone as a relapse-prevention treatment for cocaine dependence. J Clin Psychiatry. 2014 Jul;75(7):757-64. doi: 10.4088/JCP.13m08862.

Amico KR, Fisher WA, Cornman DH, Shuper PA, Redding CG, Konkle-Parker DJ, Barta W, Fisher JD. Visual analog scale of ART adherence: association with 3-day self-report and adherence barriers. J Acquir Immune Defic Syndr. 2006 Aug 1;42(4):455-9. doi: 10.1097/01.qai.0000225020.73760.c2.

Feldman BJ, Fredericksen RJ, Crane PK, Safren SA, Mugavero MJ, Willig JH, Simoni JM, Wilson IB, Saag MS, Kitahata MM, Crane HM. Evaluation of the single-item self-rating adherence scale for use in routine clinical care of people living with HIV. AIDS Behav. 2013 Jan;17(1):307-18. doi: 10.1007/s10461-012-0326-7.

Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, Wilson IB. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008 Jan;12(1):86-94. doi: 10.1007/s10461-007-9261-4. Epub 2007 Jun 19.

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Dhalla S, Kopec JA. The CAGE questionnaire for alcohol misuse: a review of reliability and validity studies. Clin Invest Med. 2007;30(1):33-41. doi: 10.25011/cim.v30i1.447.

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Helander A, Hansson T. [National harmonization of the alcohol biomarker PEth]. Lakartidningen. 2013 Sep 25-Oct 8;110(39-40):1747-8. No abstract available. Swedish.

Wurst FM, Thon N, Yegles M, Schruck A, Preuss UW, Weinmann W. Ethanol metabolites: their role in the assessment of alcohol intake. Alcohol Clin Exp Res. 2015 Nov;39(11):2060-72. doi: 10.1111/acer.12851. Epub 2015 Sep 7.

Deschamps AE, Van Wijngaerden E, Denhaerynck K, De Geest S, Vandamme AM. Use of electronic monitoring induces a 40-day intervention effect in HIV patients. J Acquir Immune Defic Syndr. 2006 Oct 1;43(2):247-8. doi: 10.1097/01.qai.0000246034.86135.89. No abstract available.

Maruotti A. A two-part mixed-effects pattern-mixture model to handle zero-inflation and incompleteness in a longitudinal setting. Biom J. 2011 Sep;53(5):716-34. doi: 10.1002/bimj.201000190. Epub 2011 Aug 24.

Oni T, Burke R, Tsekela R, Bangani N, Seldon R, Gideon HP, Wood K, Wilkinson KA, Ottenhoff TH, Wilkinson RJ. High prevalence of subclinical tuberculosis in HIV-1-infected persons without advanced immunodeficiency: implications for TB screening. Thorax. 2011 Aug;66(8):669-73. doi: 10.1136/thx.2011.160168. Epub 2011 May 31.

Cox JA, Lukande RL, Nelson AM, Mayanja-Kizza H, Colebunders R, Van Marck E, Manabe YC. An autopsy study describing causes of death and comparing clinico-pathological findings among hospitalized patients in Kampala, Uganda. PLoS One. 2012;7(3):e33685. doi: 10.1371/journal.pone.0033685. Epub 2012 Mar 14.

Hoffmann CJ, Charalambous S, Thio CL, Martin DJ, Pemba L, Fielding KL, Churchyard GJ, Chaisson RE, Grant AD. Hepatotoxicity in an African antiretroviral therapy cohort: the effect of tuberculosis and hepatitis B. AIDS. 2007 Jun 19;21(10):1301-8. doi: 10.1097/QAD.0b013e32814e6b08.

Guo N, Marra CA, Marra F, Moadebi S, Elwood RK, Fitzgerald JM. Health state utilities in latent and active tuberculosis. Value Health. 2008 Dec;11(7):1154-61. doi: 10.1111/j.1524-4733.2008.00355.x. Epub 2008 May 16.

Kirenga BJ, Worodria W, Massinga-Loembe M, Nalwoga T, Manabe YC, Kestens L, Colebunders R, Mayanja-Kizza H. Tuberculin skin test conversion among HIV patients on antiretroviral therapy in Uganda. Int J Tuberc Lung Dis. 2013 Mar;17(3):336-41. doi: 10.5588/ijtld.12.0298.

Swaminathan S, Ramachandran R, Baskaran G, Paramasivan CN, Ramanathan U, Venkatesan P, Prabhakar R, Datta M. Risk of development of tuberculosis in HIV-infected patients. Int J Tuberc Lung Dis. 2000 Sep;4(9):839-44.

Whalen CC, Johnson JL, Okwera A, Hom DL, Huebner R, Mugyenyi P, Mugerwa RD, Ellner JJ. A trial of three regimens to prevent tuberculosis in Ugandan adults infected with the human immunodeficiency virus. Uganda-Case Western Reserve University Research Collaboration. N Engl J Med. 1997 Sep 18;337(12):801-8. doi: 10.1056/NEJM199709183371201.

Fitzgerald DW, Desvarieux M, Severe P, Joseph P, Johnson WD Jr, Pape JW. Effect of post-treatment isoniazid on prevention of recurrent tuberculosis in HIV-1-infected individuals: a randomised trial. Lancet. 2000 Oct 28;356(9240):1470-4. doi: 10.1016/S0140-6736(00)02870-1.

Golub JE, Cohn S, Saraceni V, Cavalcante SC, Pacheco AG, Moulton LH, Durovni B, Chaisson RE. Long-term protection from isoniazid preventive therapy for tuberculosis in HIV-infected patients in a medium-burden tuberculosis setting: the TB/HIV in Rio (THRio) study. Clin Infect Dis. 2015 Feb 15;60(4):639-45. doi: 10.1093/cid/ciu849. Epub 2014 Nov 2.

International Union Against Tuberculosis Committee on Prophylaxis. Efficacy of various durations of isoniazid preventive therapy for tuberculosis: five years of follow-up in the IUAT trial. International Union Against Tuberculosis Committee on Prophylaxis. Bull World Health Organ. 1982;60(4):555-64.

Nakagawa F, May M, Phillips A. Life expectancy living with HIV: recent estimates and future implications. Curr Opin Infect Dis. 2013 Feb;26(1):17-25. doi: 10.1097/QCO.0b013e32835ba6b1.

Mills EJ, Bakanda C, Birungi J, Mwesigwa R, Chan K, Ford N, Hogg RS, Cooper C. Mortality by baseline CD4 cell count among HIV patients initiating antiretroviral therapy: evidence from a large cohort in Uganda. AIDS. 2011 Mar 27;25(6):851-5. doi: 10.1097/QAD.0b013e32834564e9.

Lewden C, Chene G, Morlat P, Raffi F, Dupon M, Dellamonica P, Pellegrin JL, Katlama C, Dabis F, Leport C; Agence Nationale de Recherches sur le Sida et les Hepatites Virales (ANRS) CO8 APROCO-COPILOTE Study Group; Agence Nationale de Recherches sur le Sida et les Hepatites Virales (ANRS) CO3 AQUITAINE Study Group. HIV-infected adults with a CD4 cell count greater than 500 cells/mm3 on long-term combination antiretroviral therapy reach same mortality rates as the general population. J Acquir Immune Defic Syndr. 2007 Sep 1;46(1):72-7. doi: 10.1097/QAI.0b013e318134257a.

Badri M, Lawn SD, Wood R. Short-term risk of AIDS or death in people infected with HIV-1 before antiretroviral therapy in South Africa: a longitudinal study. Lancet. 2006 Oct 7;368(9543):1254-9. doi: 10.1016/S0140-6736(06)69117-4.

Masiira B, Baisley K, Mayanja BN, Kazooba P, Maher D, Kaleebu P. Mortality and its predictors among antiretroviral therapy naive HIV-infected individuals with CD4 cell count >/=350 cells/mm(3) compared to the general population: data from a population-based prospective HIV cohort in Uganda. Glob Health Action. 2014 Jan 15;7:21843. doi: 10.3402/gha.v7.21843. eCollection 2014.

Bendavid E, Grant P, Talbot A, Owens DK, Zolopa A. Cost-effectiveness of antiretroviral regimens in the World Health Organization's treatment guidelines: a South African analysis. AIDS. 2011 Jan 14;25(2):211-20. doi: 10.1097/QAD.0b013e328340fdf8.

Jelsma J, Maclean E, Hughes J, Tinise X, Darder M. An investigation into the health-related quality of life of individuals living with HIV who are receiving HAART. AIDS Care. 2005 Jul;17(5):579-88. doi: 10.1080/09540120412331319714.

Friend-du Preez N, Peltzer K. HIV symptoms and health-related quality of life prior to initiation of HAART in a sample of HIV-positive South Africans. AIDS Behav. 2010 Dec;14(6):1437-47. doi: 10.1007/s10461-009-9566-6. Epub 2009 May 13.

Shea KM, Kammerer JS, Winston CA, Navin TR, Horsburgh CR Jr. Estimated rate of reactivation of latent tuberculosis infection in the United States, overall and by population subgroup. Am J Epidemiol. 2014 Jan 15;179(2):216-25. doi: 10.1093/aje/kwt246. Epub 2013 Oct 18.

Durovni B, Saraceni V, Moulton LH, Pacheco AG, Cavalcante SC, King BS, Cohn S, Efron A, Chaisson RE, Golub JE. Effect of improved tuberculosis screening and isoniazid preventive therapy on incidence of tuberculosis and death in patients with HIV in clinics in Rio de Janeiro, Brazil: a stepped wedge, cluster-randomised trial. Lancet Infect Dis. 2013 Oct;13(10):852-8. doi: 10.1016/S1473-3099(13)70187-7. Epub 2013 Aug 16.

Bounthavong M, Hsu DI, Okamoto MP. Cost-effectiveness analysis of linezolid vs. vancomycin in treating methicillin-resistant Staphylococcus aureus complicated skin and soft tissue infections using a decision analytic model. Int J Clin Pract. 2009 Mar;63(3):376-86. doi: 10.1111/j.1742-1241.2008.01958.x.

Frey HC, Patil SR. Identification and review of sensitivity analysis methods. Risk Anal. 2002 Jun;22(3):553-78.

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