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2. Avanti 3: A Randomized, Double-Blind Trial to Compare the Efficacy and Safety of Lamivudine plus Zidovudine versus Lamivudine plus Zidovudine plus Nelfinavir in HIV-1-Infected Antiretroviral-Naive Patients

Author

Gartland, Martin, Clumeck, N, Cooper, DA, Gatell, J, Gazzard, B, Gerstoft, J, Goebel, F, Lange, J, Montaner, J, Reiss, P, Rozenbaum, W, Vella, S, Cooper, DA, Haberl, M, Clumeck, N, Luyts, D, Montaner, J., Rachlis, A, Marina, R, Gerstoft, J, Mathiesen, L, Soelberg, U, Molina, J-M, Pialloux, G, Rozenbaum, W, Cosby, C, Goebel, FD, Staszewski, S, Hug, M, Milazzo, F, Moroni, M, Panebianco, R, Clotet, B, Artigas, JM Gatell, GonzalezLahoz, J, Leal, M, Gandarias, B, Gazzard, B, Johnson, M, Watkins, K, Page, V, Sandstrom, E, Darbyshire, J, Petersen, A, Athisegaran, R, Coughlan, M, Fiddian, P, Gartland, M, Harrigan, R, Henry, T, Larder, B, Maguire, M, Millard, J, Moore, S, Patel, K, Shortino, D, Tisdale, M, Vafidis, I, and Yeo, J

Abstract

The objective of our randomized, multicentre, double-blind, placebo-controlled study was to investigate the safety, tolerability, and antiretroviral and immunological effect of double and triple combination therapy regimens. A total of 105 antiretroviral therapy-naive patients were randomized to receive either zidovudine (300 mg twice per day) plus lamivudine (150 mg twice per day) plus nelfinavir placebo (three times per day) (n=52), or zidovudine/lamivudine (dose as before) plus nelfinavir (750 mg three times per day) (n=53) for 28 weeks. After this time, patients were allowed to switch to open-label zidovudine/lamivudine/nelfinavir. The overall log10reduction from baseline in plasma HIV-1 RNA was significantly greater in the zidovudine/lamivudine/nelfinavir group than the zidovudine/lamivudine group (P=0.001; median treatment difference, –1.01 log10copies/ml; 95% confidence interval –1.23 to –0.79), as measured by the average area under the curve minus baseline over 28weeks. Increases from baseline in CD4 cell counts were statistically significantly greater in the zidovudine/lamivudine/nelfinavir group (101.5 cells/ml) than the zidovudine/lamivudine group (47.0 cells/ml; P=0.027) at week 28.Of note, the addition of nelfinavir from weeks 28–52 led to an increase in the proportion of subjects with plasma HIV-1 RNA <400 copies/ml from 17% (9/52 patients on zidovudine/lamivudine) to 50% (13/26 patients who switched to zidovudine/lamivudine/nelfinavir). Incidence of drug-related adverse events was similar in the two groups, except for nausea (more common in zidovudine/lamivudine group; 40 versus 17%) and diarrhoea (more common in zidovudine/lamivudine/nelfinavir group; 45 versus 14%). In conclusion, our study confirms the efficacy of triple combination therapy with two nucleoside analogues and a protease inhibitor compared with double-nucleoside therapy. Interestingly, the addition of nelfinavir to zidovudine/lamivudine, even after 6 months of double nucleoside therapy, led to a substantial virological benefit that was sustained over 24weeks in a subset of patients.

Published
2001
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3. Simplification with abacavir-based triple nucleoside therapy versus continued protease inhibitor-based highly active antiretroviral therapy in HIV-1-infected patients with undetectable plasma HIV-1 RNA.

Author

Clumeck N, Goebel F, Rozenbaum W, Gerstoft J, Staszewski S, Montaner J, Johnson M, Gazzard B, Stone C, Athisegaran R, and Moore S

Subjects
Adult, Aged, Drug Therapy, Combination, Female, HIV Infections virology, HIV-1 isolation & purification, HIV-1 physiology, Humans, Male, Middle Aged, RNA, Viral blood, Treatment Outcome, Anti-HIV Agents therapeutic use, Dideoxynucleosides therapeutic use, HIV Infections drug therapy, HIV Protease Inhibitors therapeutic use, Reverse Transcriptase Inhibitors therapeutic use
Abstract

Objective: To assess the antiviral efficacy, safety and adherence in patients switched to an abacavir-containing nucleoside reverse transcriptase inhibitor (NRTI) regimen after long-term HIV-1 RNA suppression with a dual NRTI/protease inhibitor (PI) combination., Methods: In an open-label, multicentre study, patients receiving 2NRTI plus PI for at least 6 months, with a history of undetectable plasma HIV-1 RNA since the initiation of therapy and plasma HIV-1 RNA < 50 copies/ml at screening, were randomly assigned to replace the PI with abacavir (n = 105) or continue the same treatment (n = 106). Clinical assessments included plasma HIV-1 RNA, chemistry, haematology, lymphocyte counts, and adverse event reports. Adherence to treatment was assessed by patient self-report., Results: A significantly longer time to treatment failure was demonstrated in the abacavir arm compared with the PI arm (P = 0.03) while treatment failure was experienced by significantly more patients in the PI arm: 24 (23%) versus 12 (12%) (P = 0.03). Therapy-limiting toxicity led to treatment failure in eight versus 14 cases in the abacavir and PI arms, respectively, whereas virological rebound was the cause in four versus two cases. Significant reductions in cholesterol and non-fasting triglyceride plasma levels at 48 weeks were observed in the abacavir arm (P < 0.001 andP = 0.035, respectively). The number of patients reporting no difficulty in taking their therapy showed a marked increase from baseline in the abacavir arm., Conclusion: The replacement of PI by abacavir in a triple combination regimen following prolonged suppression of plasma HIV-1 RNA provides continued virological suppression, significant improvements in lipid abnormalities and enhanced ease of dosing.

Published
2001
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