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Result Summary for NUCB3002

Result Summary

Protocol ID:	NUCB3002
Clinical Study ID:	NUCB3002
Official Title:	A Randomized, Controlled, Lamivudine (3TCTM) Double-Blinded Trial to Compare the Safety and Efficacy of Zidovudine (ZDV) Monotherapy Versus Lamivudine Plus ZDV in Combination in Treating HIV-1 Infected Patients who are Zidovudine Therapy-Experienced With a CD4+ Cell Count Between 100cells/mm3 to ...
Phase:	Phase 3
Study Indications or Diseases:	Infection, Human Immunodeficiency Virus I
Generic Name:	lamivudine
Trade/Product Name:	epivir;epivir
Approved Drug Label:	http://www.gsk.com/products.html
Results Summary:	Click here to download result summary.
Citations:	Johnson VA, Overbay CB, Koel JL, Nail CD, Bartlett JA, Quinn JB, et al. Drug resistance, viral load, and SI phenotype in NUCA 3002: Combined 3TC/ZDV therapy over a maximum of 52 weeks in ZDV-experienced (<= 24 weeks) patients (CD4 = 100-300/mm3. 4 CONF. RETROVIRUSES OPPORTUNISTIC INFECT. 1997;416 Larder BA. The influence of combination therapy on HIV-1 viral load and drug resistance. AIDS 1994;8(Suppl 4):S4 Stazewski S, Bartlett J, Eron J, Katlama C, Johnson J, Hill AM Reductions in HIV-1 disease progression for AZT/3TC relative to control treatments: a meta analysis Intl Conf AIDS 1996 Jul 7-12 (abstract no. THB948) Phillips AN, Eron JJ, Bartlett JA, Rubin M, Johnson J, Price S, et al. HIV-1 RNA levels and the development of clinical disease. AIDS 1996;10(8):859-865 Miller V, Staszewski S, Pauwels R, De Bethune MP, Hertogs K, Larder BA, et al. Drug resistance patterns in HIV-1 isolates from patients receiving prolonged AZT/3TC combination therapy. AIDS 1996;10 SUPPL. 2:S19 Kemp SD, Harrigan PR, Kinghorn I, Kohli A, Larder BA, Katlama C. Antiviral potency of AZT + 3TC combination therapy in vivo supports in vitro virological observations. AIDS 1994;8(Suppl 4):S20 Moore KHP, Yuen GJ, Hussey EK, Pakes GE, Eron JJ Jr, Bartlett JA. Population pharmacokinetics of lamivudine in adult human immunodeficiency virus-infected patients enrolled in two phase III clinical trials. ANTIMICROB. AGENTS CHEMOTHER. 1999;43(12):3025-3029 Katlama C. Ingrand D. Loveday C. Clumeck N. Mallolas J. Staszewski S. Johnson M. Hill AM. Pearce G. McDade H. Safety and efficacy of lamivudine-zidovudine combination therapy in antiretroviral-naive patients. A randomized controlled comparison with zidovudine monotherapy. Lamivudine European HIV Working Group.[see comment]. [Clinical Trial. Journal Article. Multicenter Study. Randomized Controlled Trial] JAMA. 276(2):118-25, 1996 Jul 10 Staszewski S. Zidovudine and lamivudine: Results of phase III studies. J. ACQUIRED IMMUNE DEFIC. SYNDR. HUM. RETROVIROL. 1995; 10(SUPPL 1):S57 Yuen GJ, Benoit S, Rubin M. Population (POP) pharmacokinetics (PK) of lamivudine (3TC) in HIV infected patients: Results from two phase III clinical trials. CLIN. PHARMACOL. THER. 1996;59(2):144 Resistance profiles in patients with viral rebound on potent antiretroviral therapy. Cozzi Lepri, A., Sabin, C. A., Staszewski, S., Hertogs, K., Muller, A., Rabenau, H., Phillips, A. N., and Miller, V. J Infect Dis 2000; 181. 181(3. 3):1143-7, 1143-7.