Scientific and ethical considerations in trial design for investigational agents for the treatment of human immunodeficiency virus infection

Clinical Infectious Diseases

Volumn 36, Issue 2, 2003, Pages 201-206

  Feinberg, Judith ^a   Japour, Anthony J ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ABACAVIR; ADEFOVIR DIPIVOXIL; AMPRENAVIR; ANTIRETROVIRUS AGENT; EFAVIRENZ; ENFUVIRTIDE; INDINAVIR; LAMIVUDINE; LOPINAVIR; NELFINAVIR; NEVIRAPINE; PENICILLIN G; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; STAVUDINE;

ADULT; ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE CALCULATION; DOUBLE BLIND PROCEDURE; DRUG APPROVAL; DRUG DESIGN; DRUG EFFECT; DRUG EXPOSURE; DRUG INDUSTRY; DRUG RESEARCH; ETHICS; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE ORGANIZATION; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INTERNATIONAL COOPERATION; LIVER FAILURE; MAJOR CLINICAL STUDY; NEPHROTOXICITY; NONHUMAN; PATIENT SELECTION; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PUBLIC HEALTH SERVICE; RANDOMIZED CONTROLLED TRIAL; SCIENCE; TECHNIQUE; TREATMENT OUTCOME; UNITED STATES; UNIVERSITY; VIRUS RESISTANCE;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

ANTI-HIV AGENTS; BIOMEDICAL RESEARCH; CLINICAL TRIALS; CLINICAL TRIALS, PHASE I; CLINICAL TRIALS, PHASE II; CLINICAL TRIALS, PHASE III; DRUGS, INVESTIGATIONAL; ETHICS, CLINICAL; HIV INFECTIONS; HUMANS; RESEARCH DESIGN;

EID: 0037439392     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/367568     Document Type: Article

References (28)

1. Fauci AS. Infectious diseases: considerations for the 21st century. Clin Infect Dis 2001; 32:675-85.
2. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report. Washington, DC: US Government Printing Office, 1979.
3. Jones JH. Bad blood: the Tuskegee syphilis experiment. New York: The Free Press, 1993.
4. Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. Available at http://www.hivatis.org. Updated 13 August 2001.
5. Carpenter CC, Cooper DA, Fischl MA, et al. Updated recommendations of the International AIDS Society - USA panel. JAMA 2000; 283:381-90.
6. Viramune [package insert]. Ridgefield, CT: Boehringer Ingelheim, 2001.
7. Kuritzkes DR, Shugarts D, Bahktiari M, et al. Emergence of dual resistance to zidovudine and lamivudine in HIV-1-infected patients treated with zidovudine plus lamivudine as initial therapy. J Acquir Inmmune Defic Syndr 2000; 23:26-34.
8. Eron JJ, Kessler H, Thompson M, et al. Clinical HIV suppression after short-term monotherapy with DAPD [abstract 690]. In: Program and abstracts of the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy (Toronto). Washington, DC: American Society for Microbiology, 2000.
9. Gruzdev B, Rakhmanova A, De Dier K, et al. TMC125 is a highly potent non-nucleoside reverse transcriptase inhibitor (NNRTI) in antiretroviral therapy (ART) naïve, HIV-1 infected subjects [abstract 668]. In: Program and abstracts of the 41st Interscience Conference on Antimicrobial Agents and Chemotherapy (Chicago). Washington, DC: American Society, for Microbiology, 2001.
10. Lalezari J, Wheeler D, Kilby M, et al. Comparative PK of carbonate and Tris buffer formulations of the peptide HIV fusion inhibitor T-20 [abstract 1936]. In: Program and abstracts of the 41st Interscience Conference on Antimicrobial Agents and Chemotherapy (Chicago). Washington, DC: American Society for Microbiology, 2001.
11. Office of the Secretary. International Conference on Harmonisation. Guidance on general considerations for clinical trials. Federal Register 1997; 62:66113-9.
12. Haubrich R, Thompson M, Schooley R, et al. A phase II safety and efficacy study of amprenavir (APV) in combination with zidovudine and lamivudine in HIV-infected patients with limited antiretroviral experience. AIDS 1999; 13:2411-20.
13. Murphy R, Gulick R, DeGruttola V, et al. Treatment with amprenavir alone or amprenavir with zidovudine and lamivudine in adults with human immunodeficiency virus infection. J Infect Dis 1999; 179:808-16.
14. Murphy R, Brun S, Hicks C, et al. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS 2001; 15:F1-9.
15. Cahn P, Percival L, Phanuphak P, et al. Phase II 24-week data from study AI424-008: comparative results of BMS-232632, stavudine, lamivudine as HAART for treatment-naive HIV-infected patients [abstract 5]. In: Program and abstracts of the 1st IAS Conference on HIV Pathogenesis and Treatment (Buenos Aires). 2001.
16. Bartlett J, DeMasi R, Quinn J, et al. Overview of the effectiveness of triple combination therapy in antiretroviral-naive HIV-1 infected adults. AIDS 2001; 15:1369-77.
17. Notermans D, Jurriaans S, de Wolf F, et al. Decrease of HIV-1 RNA levels in lymphoid tissue and peripheral blood during treatment with ritonavir, lamivudine, and zidovudine. AIDS 1998; 12:167-73.
18. Benson C, Deeks S, Brun S, et al. Safety and antiviral activity at 48 weeks of lopinavir/ritonavir plus nevirapine and 2 nucleoside reverse-transcriptase inhibitors in human immunodeficiency virus-infected protease inhibitor-experienced patients. J Infect Dis 2002; 185:599-607.
19. Squires K, Gatell, J, Piliero P, et al. AI424-007: 48-week safety and efficacy results from a phase II study of once-daily HIV-1 protease inhibitor (PI), BMS-232632 [abstract 15]. In: Program and abstracts of the 8th Conference on Retroviruses and Opportunistic Infections (Chicago). Alexandria, Virginia: Foundation for Retrovirology and Human Health, 2001.
20. Kahn J, Lagakos S, Wulfsohn M. Efficacy and safety of adefovir dipivoxil with antiretroviral therapy: a randomized controlled trial. JAMA 1999; 282:2305-12.
21. Mellors J. Adefovir for the treatment of HIV infection: if not now, when? JAMA 1999; 282:2355-6.
22. Saag M, Tebas P, Sension M, et al. Randomized, double-blind comparison of two nelfinavir doses plus nucleosides in HIV-infected patients (Agouron study 511). AIDS 2001; 15:1971-8.
23. Fischl MA, Richman DD, Grieco MH, et al. The efficacy of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex: a double-blind, placebo-controlled trial. N Engl J Med 1987; 317:185-91.
24. Cameron DW, Heath-Chiozzi M, Danner S, et al. Randomised placebo-controlled trial of ritonavir in advanced HIV-1 disease. Lancet 1998; 351:543-9.
25. Bentar S, Singer P. A new look at international research ethics. BMJ 2000; 321:824-6.
26. Office of the Secretary. International Conference on Harmonisation. Guidance on statistical principles for clinical trials. Federal Register 1998; 63:49583-98.
27. Staszewski S, Morales-Ramirez J, Tashima K, et al. Efavirenz plus zidovudine and lamivudine, efavirenz plus indinavir, and indinavir plus zidovudine and lamivudine in the treatment of HIV-1 infection in adults. N Engl J Med 1999; 341:1865-73.
28. Sustiva [package insert]. Wilmington, DE: DuPont Pharmaceuticals, 1998.