Antiviral activity of enteric-coated didanosine, stavudine, and nelfinavir versus zidovudine plus lamivudine and nelfinavir

Journal of Acquired Immune Deficiency Syndromes

Volumn 31, Issue 4, 2002, Pages 399-403

  Gathe Jr , Joseph ^a   Badaro, Roberto ^b   Grimwood, Ashraf ^c,d   Abrams, Lori ^d   Klesczewski, Ken ^d   Cross, Anne ^d   McLaren, Colin ^d  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

^b FEDERAL UNIVERSITY OF BAHIA   (Brazil)

^c Woodstock   (South Africa)

^d BRISTOL MYERS SQUIBB   (United States)

Author keywords

Antiretroviral therapy; Clinical trials; Combination therapy; Protease inhibitors; Reverse transcriptase inhibitors; Viral load

Indexed keywords

ANTIRETROVIRUS AGENT; DIDANOSINE; LAMIVUDINE; NELFINAVIR; STAVUDINE; ZIDOVUDINE;

ADULT; ANTIVIRAL ACTIVITY; ARTICLE; CLINICAL TRIAL; DIARRHEA; DRUG EFFECT; DRUG EFFICACY; DRUG INDUCED DISEASE; DRUG RESPONSE; DRUG SAFETY; ENTERIC COATED TABLET; HEMATOLOGIC DISEASE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LIVER DYSFUNCTION; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NEUROLOGIC DISEASE; PANCREATITIS; PRIORITY JOURNAL; RANDOMIZATION; RASH; TREATMENT OUTCOME;

EID: 0036893169     PISSN: 15254135     EISSN: None     Source Type: Journal    
DOI: 10.1097/00126334-200212010-00005     Document Type: Article

References (17)

1. Hoetelmans RW, van Heeswijk RP, Profijt M, et al. Comparison of the plasma pharmacokinetics and renal clearance of didanosine during once and twice daily dosing in HIV-1-infected individuals. AIDS 1998;12:F211-6.
2. Monno L, Cargnel A, Soranzo ML, et al. Comparison of once and twice daily dosing of didanosine in combination with stavudine for the treatment of HIV-1 infection. Antiviral Ther 1999;4:195-202.
3. Mobley JE, Pollard RB, Schrader S, et al. Virological and immunologic responses to once-daily dosing of didanosine in combination with stavudine. AIDS 1999;13:F87-93.
4. Keiser P, Turner D, Ramilo O, et al. An open-label pilot study of the efficacy and tolerability of once-daily didanosine versus twice-daily didanosine. Clin Infect Dis 1998;27:400-1.
5. Knupp C, Ullah I, Wiley G, et al. Evaluation of two enteric coated formulations of didanosine (ddI) using pharmacokinetics (PK) and γ scintigraphy in healthy male subjects [abstract 1663]. 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, September 2000.
6. Effect of Food on the Bioavailability of Didanosine, Administered as an Encapsulated Enteric-coated Formulation, in Healthy Volunteers (Study AI454-153). Bristol-Myers Squibb, 1999 (data on file).
7. Knupp C, Damle B, Nichola P, et al. Bioequivalence of two formulations of didanosine (ddI), enteric-coated and the chewable tablet, in healthy volunteers and subjects infected with HIV [abstract 1664]. 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, September 2000.
8. Mummaneni V, Damle B, Kaul S, et al. Lack of effect of didanosine encapsulated enteric-coated beadlet formulation on the pharmacokinetics of indinavir, ketoconazole, and ciprofloxacin in healthy subjects [abstract 1629]. 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, September 2000.
9. Diggle PJ, Liang K-Y, Zeger SL. Analysis of Longitudinal Data. New York: Oxford University Press, 1994.
10. Kalbfleisch JD, Prentice RL. The Statistical Analysis of Failure Time Data. New York: John Wiley & Sons, 1980.
11. Fleiss JL. Statistical Methods for Rates and Proportions. New York: Wiley, 1973.
12. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of Anti-infective Drug Products. Points to Consider. November 26, 1996.
13. Kunches LM, Reinhalter NE, Marquis A, et al. Tolerability of enteric-coated didanosine capsules compared with didanosine tablets in adults with HIV infection. J Acquir Immune Defic Syndr 2001;28:150-3.
14. Maggiolo F, Migliorino M, Maserati R, et al. Virologic and immunologic responses to a once-a-day antiviral regimen with didanosine, lamivudine and efavirenz. Antiviral Ther 2001;6: 249-53.
15. Haberl A, Gute P, Carlebach A, et al. Once-daily therapy (NVP/ddI/3TC) for the IVDU HIV-1-infected population of the Frankfurt HIV-cohort [abstract 22398]. 12th World AIDS Conference, Geneva, June-July 1998.
16. Schrader S, Sharma S, Seekins D, et al. Comparison of HIV RNA suppression produced by triple regimens containing either didanosine enteric-coated or didanosine tablet formulations each administered once daily. 8th Conference on Retroviruses and Opportunistic Infections, Chicago, February 2001.
17. Gathe J, Benetucci J, Lupo S, et al. Comparison of a triple regimen containing once-daily didanosine versus a regimen of zidovudine plus lamivudine plus nelfinavir [poster 1973]. 39th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, September 1999.