Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents

US Health & Human Services, December 1998

References

1. USPHS/IDSA Prevention of Opportunistic Infections Working Group: 1997 USPHS/IDSA guidelines for the prevention of opportunistic infections in persons infected with human immunodeficiency virus. MMWR. 1997;46 (No. RR-12):1-46.
2. Perelson A, Essunger Y, Cao Y, et al: Decay characteristics of HIV-1-infected compartments during combination therapy. Nature. 1997;387:188-191.
3. Stein D, Korvick J, Vermund S: CD4⁺ lymphocyte cell enumeration for prediction of clinical course of human immunodeficiency virus disease: A review. J Infect Dis. 1992;165:352- 363.
4. Carpenter C, Fischl M, Hammer S, et al: Updated recommendations of the International AIDS Society Panel -- USA Panel. JAMA. 1997;277:1962-1969.
5. Raboud J, Montaner J, Conway B, et al: Variation in plasma RNA levels, CD4 cell counts, and p24 antigen levels in clinically stable men with human immunodeficiency virus infection. J Infect Dis. 1996;174:191-194.
6. CDC. 1993 Revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR 1992; 41(No. RR-17).
7. Fischl M, Richman D, Grieco M, et al: The efficacy of azidothymidine in the treatment of patients with AIDS and AIDS-related complex: A double blind, placebo controlled trial. N Engl J Med. 1987;317:185-191.
8. Fischl M, Richman D, Hansen H, et al: The safety and efficacy of zidovudine in the treatment of subjects with mildly symptomatic human immunodeficiency virus type 1 infection: A double blind, placebo controlled trial. Ann Intern Med. 1990;112:727-737.
9. Volberding P, Lagakos S, Koch M, et al: Zidovudine in asymptomatic human immunodeficiency virus infection: A controlled trial in persons with fewer than 500 CD4- positive cells per cubic millimeter. N Engl J Med. 1990;322:941-949.
10. Volberding P, Lagakos S, Grimes J, et al: The duration of zidovudine benefit in persons with asymptomatic HIV infection: Prolonged evaluation of protocol 019 of the AIDS Clinical Trials Group. JAMA. 1994;272:437-442.
11. Hammer S, Katzenstein D, Hughes M, et al: A trial comparing nucleoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200 to 500 per cubic millimeter. N Engl J Med. 1996;335:1081-1090.
12. Mellors J, Munoz A, Giorgi J, et al: Plasma viral load and CD4⁺ lymphocytes as prognostic markers of HIV-1 infection. Ann Intern Med. 1997;126:946-954.
13. Schuurman R, Nijhuis M, van Leeuwen R, et al: Rapid changes in human immunodeficiency virus type 1 RNA load and appearance of drug-resistant virus populations in persons treated with Lamivudine (3TC), J Infec Dis. 1995;171:1411-1419.
14. Keulen W, Back N, van Wijk A, et al: Initial appearance of the 184lle variant in Lamivudine-treated patients is caused by the mutational bias of human immunodeficiency virus type 1 reverse transcriptase. J Virol. 1997;71:3346-3350.
15. Centers for Disease Control and Prevention: Clinical Update -- Impact of HIV protease inhibitors on the treatment of HIV infected tuberculosis patients with rifampin. MMWR. 1996;45:921-925.
16. Schacker T, Collier A, Hughes J, et al: Clinical and epidemiologic features of primary HIV infection. Ann Intern Med. 1996;125:257-264.
17. Kinloch-de Loes S, de Saussure P, Saurat J, et al: Symptomatic primary infection due to human immunodeficiency virus type 1: Review of 31 cases. Clin Infect Dis. 1993;17:59-65.
18. Tindall B, Cooper D: Primary HIV infection: Host responses and intervention strategies. AIDS. 1991;5:1-14.
19. Niu M, Stein D, Schnittman S: Primary Human Immunodeficiency Virus Type 1 Infection: Review of Pathogenesis and Early Treatment Intervention in Humans and Animal Retrovirus Infections. J Infect Dis. 1993; 168:1490-1501.
20. Lafeuillade A, Poggi C, Tamalet C, et al: Effects of a combination of Zidovudine, Didanosine, and Lamivudine on primary human immunodeficiency virus type 1 infection. J Infect Dis. 1997;175:1051-1055.
21. Centers for Disease Control and Prevention: Update: Provisional public health service recommendations for chemoprophylaxis after occupational exposure to HIV. MMWR. 1996;45:468-480.
22. Hoen B, Harzic M, Fleury H, et al: ANRS053 trial of Zidovudine, Lamivudine, and Ritonavir combination in patients with symptomatic primary HIV-1 infection: Preliminary results. 4 th Conference on Retroviruses and Opportunistic Infections. Washington DC, Jan 22-26, 1997. Abstract 232. Page 107.
23. Tamalet C, Poizot Martin I, LaFeuillade A, et al: Viral load and genotypic resistance pattern in HIV-1 infected patients treated by a triple combination therapy including nucleoside and protease inhibitors initiated at primary infection. 4 th Conference on Retroviruses and Opportunistic Infections. Washington DC, Jan 22-26, 1997. Abstract 592. Page 174.
24. Perrin L, Markowitz M, Calandra G, et al: An open treatment study of acute HIV infection with Zidovudine, Lamivudine and Indinavir sulfate. 4 th Conference on Retroviruses and Opportunistic Infections. Washington DC, Jan 22-26, 1997. Abstract 238. Page 108.
25. Minkoff H, Augenbraun M: Antiretroviral therapy for pregnant women. Am J Obstet Gynecol. 997;176:478-489.
26. Centers for Disease Control and Prevention: Pregnancy outcomes following systemic prenatal acyclovir exposure -- June 1, 1984-June 30, 1993. MMWR. 1993;42:806-809.
27. O'Sullivan M, Boyer P, Scott G, et al: The pharmacokinetics and safety of zidovudine in the third trimester of pregnancy for women infected with human immunodeficiency virus and their infants: Phase I Acquired Immunodeficiency Syndrome Clinical Trials Group study (protocol 082). AM J Obstet Gynecol. 1993;168:1510-1516.
28. Moodley J, Moodley D, Pillay K, et al: Antiviral effect of lamivudine alone and in combination with zidovudine in HIV-infected pregnant women. Proceedings of the Fourth Conference on Retroviruses and Opportunistic Infections, Washington DC, January 22-26, 1997. Abstract 607. Page 176.
29. Sandberg J, Slikker W: Developmental pharmacology and toxicology of anti-HIV therapeutic agents Dideoxynucleosides. FASEB J. 1995;9:1157-1163.
30. Mirochnick M, Fenton T, Gagnier P, et al. Pharmacokinetics of nevirapine in human immunodeficiency virus type 1-infected pregnant women and their neonates. J Infect Dis 1998; 178:368-374.
31. Pediatric AIDS Clinical Trials Group Protocol 382, Version 2.0, May 26, 1998.
32. FDA Public Health Advisory: Reports of diabetes and hyperglycemia in patients receiving protease inhibitors for the treatment of human immunodeficiency virus (HIV). JAMA. 1997;278:379.
33. Centers for Disease Control and Prevention: Public Health Service Task Force recommendations for the use of antiretroviral drugs in pregnant females infected with HIV-1 for maternal health and for reducing perinatal HIV-1 transmission in the United States. MMWR. 1998;47(RR-2).
34. Sperling R, Shapiro D, Coombs R, et al: Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus from mother to infant. N Engl J Med. 1996;335:1621-1629.
35. Rodman J, Robbins B, Flynn P, Friedland A. A systemic and cellular model for zidovudine plasma concentrations and intracellular phosphorylation in patients. J infect Dis 1996;174:490-499.
36. Barry M, Khoo S, Beal G, et al. The effect of zidovudine dose on the formulation of intracellular phosphorylated metabolites. AIDS 1996;10:1361-1367.
37. Mulder, J, Cooper D, Mathiesen L, et al. Zidovudine twice daily in asymptomatic subjects with HIV infection and a high risk of progression to AIDS: a randomized, double-blind, placebo-controlled study. AIDS 1994;8:313-321.
38. Mannucci P, Gringeri A, Savidge G, et al. Randomized, double-blind, placebo-controlled trial of twice-daily zudovudine in asymptomatic hemophiliacs infected with the human immunodeficiency virus type 1. Brit J Haematol 1994;86:174-179.
39. Cooper D, Gatell J, Kroon S, et al. Zidovudine in persons with asymptomatic HIV infection and CD4⁺ counts greater than 400 per cubic millimeter. N Engl J Med 1993;329:297-303.
40. Centers for Disease Control and Prevention. Administration of zidovudine during late pregnancy and delivery to prevent perinatal HIV transmission - Thailand, 1996-1998. MMWR 1998;47:151-154.
41. Eastman P, Shapiro D, Coombs R, et al. Maternal genotypic ZDV resistance and failure of ZDV therapy to prevent mother-child transmission. Abstracts of the 4 th Conference on Retroviruses and Opportunistic Infections. Washington, D.C., January 22-26, 1997;160 [Abstract 516]
42. Hammer S, Squires K, Hughes M, et al. A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Section. N Engl J Med. 1997;337:725-733.
43. Gulick R, Mellors J, Havlir D, et al. Treatment with indinavir, zidovudine and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy. N Engl J Med. 1997;337:734-739.
44. D'Aquila R, Hughes M, Johnson V, et al. Nevirapine, zidovudine, and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 1996;124:1019-1030.
45. Montaner J, Reiss P, Cooper D, et al. A randomized, doubled-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients. JAMA 1998;279:930-937.
46. Schapiro J, Winters M, Stewart F, et al: The effect of high-dose saquinavir on viral load and CD4⁺ T-cell counts in HIV-infected patients. Ann Intern Med. 1996; 124:1039-1050.
47. Bartlett J: Protease inhibitors for HIV infection. Ann Intern Med. 1996;124:1086-1088.
48. Eron J, Benoit S, Jemsek J, et al: Treatment with Lamivudine, Zidovudine, or both in HIV-positive patients with 200 to 500 CD4⁺ cells per cubic millimeter. N Engl J Med. 1995;333:1662-1669.
49. Staszewski S, Loveday C, Picazo J, et al: Safety and efficacy of lamivudine-zidovudine combination therapy in zidovudine-experienced patients. JAMA. 1996;276:111-117.
50. Dube M, Johnson D, Currier J, et al: Protease inhibitor-associated hyperglycaemia (letter). Lancet 1997 Sep 6;350:713-714.
51. Visnegarwala F, Krause K, Musher D: Severe diabetes associated with protease inhibitor therapy (letter). Annals of Internal Medicine 1997;127:947.
52. Eastone J, Decker C: New-onset diabetes mellitus associated with use of protease inhibitor (letter). Annals of Internal Medicine 1997;127:948.
53. Hanson C, Cooper E, Antonelli T, et al: Lack of tumors in infants with perinatal HIV exposure and fetal/neonatal exposure to zidovudine. In Proceeding of the National Conference on Women and HIV. Pasadena, CA; May 4-7, 1997:152