Publications

13

Jul, 2003

Impact of NFV and its active metabolite M8 trough levels on virologic response from primary HIV-1 vertically infected children treated with d4T, ddI and NFV in the PENTA 7 study.

 

Authors: Compagnucci A, Saidi Y, Faye A, et al.

Published in: 2nd IAS Conference on HIV Pathogenesis and Treatment, 13-16 July Paris. Poster 1095

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19

Apr, 2003

Short-term risk of disease progression in HIV-1 infected children receiving no antiretroviral therapy or zidovudine monotherapy: estimates according to CD4 percent, viral load, and age.

 

Authors: HIV Paediatric Prognostic Markers Collaborative Study Group.

Published in: Lancet 2003; 362:1605-11.

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18

Apr, 2003

Pharmacokinetics of Nelfinavir and its Active Metabolite, hydroxy-tert-butylamide, in Infants Perinatally Infected with HIV-1.

 

Authors: Litalien C, Faye A, Compagnucci A, Giaquinto C, Harper L, Gibb DM, Jacqz-Aigrain E for PENTA.

Published in: Pediatr Inf Dis J 2003; 22(1):48-55

Background In children younger than 2 years of age vertically infected with HIV-1, the recommended pediatric dosing regimen for nelfinavir (20 to 30 mg/kg three times a day) provides insufficient drug exposure. This study was conducted to determine the steady state pharmacokinetics of nelfinavir and its active metabolite, M8, in this population.

Methods Fourteen infants (2.3 to 8.5 months) underwent 18 intensive pharmacokinetic studies of nelfinavir and M8 at steady state. Nelfinavir and M8 concentrations were measured by high performance liquid chromatography coupled with mass spectrometry, and individual pharmacokinetic values were determined.

Results A mean nelfinavir daily dose of 135.7 ± 18.8 mg/kg (twice or three times a day) resulted in median Cmin, Cmax, area under the plasma concentration-time curve (AUC0–24 h) and CL/ F for nelfinavir of 0.627 mg/l, 2.39 mg/l, 30.6 mg*h/l and 4.2 liters/h/kg, respectively. When normalized for a daily dose of nelfinavir of 150 mg/kg/day, 16.7% of Cmax and 27.8% of AUC0–24 h values were below the tenth percentile for adult values.

Conclusions During the first year of life, nelfinavir requirement is much higher than in older children and adults to obtain similar drug exposure. The mechanisms underlying such differences may involve higher first past metabolism and/or drug interactions or might be related to feeding conditions.

 

18

Apr, 2003

Three year follow-up of the PENTA 5 trial

 

Authors: Gibb DM, Giaquinto C, Walker AS, Harper L, Compagnucci A, Saidi Y, Moulinier C, Aboulker JP, Babiker AG, Debré M, Darbyshire JH on behalf of the PENTA 5 Executive Committee

Published: 10th Conference on Retroviruses and Opportunistic Infections February 10th – 14th, 2003 – Boston. Poster G1-12

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18

Apr, 2003

Relationship between Cell-Associated HIV-1 DNA and Thymic Output in HIV-1 infected Children Initiating Antiretroviral Therapy in the PENTA 5 Trial

 

Authors: De Rossi A, Walker AS, De Forni D, Gibb DM on behalf of PENTA.

Published in: 10th Conference on Retroviruses and Opportunistic Infections February 10th – 14th, 2003 – Boston. Poster P-17

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18

Apr, 2003

Adherence to Prescribed Antiretroviral Therapy in Human Immunodeficiency Virus-Infected Children in the PENTA 5 Trial

 

Author: Gibb DM, Goodall RL, Giacomet V, McGee L, Compagnucci A, Lyall H. Paediatric European Network for Treatment of AIDS Steering Committee.

Published in: Pediatr Infect Dis J. 2003;22(1):56-62

Background Most studies of adherence to highly active antiretroviral therapy in children have been retrospective or cross-sectional. Factors relating to the caregiver, the child and the medication are all considered to be important for good adherence.
Methods Adherence with taking prescribed medication was assessed by questionnaires completed at 4, 12, 24 and 48 weeks by caregivers of previously untreated HIV-infected children participating in the PENTA 5 trial, which was designed to evaluate different dual nucleoside reverse transcriptase inhibitor therapy combinations with and without the protease inhibitor nelfinavir. The effects of several factors on adherence and the effect of adherence on virologic suppression were assessed by multivariate logistic regression.
Results Caregivers returned 266 questionnaires including at least 1 for 108 (84%) children in the trial. Nelfinavir was reported to be the most difficult drug to take (38% of questionnaires), but the difficulty decreased over time, P = 0.02. Comments on difficulties in taking and remembering drugs related to fear of disclosure and to unpleasant characteristics of the drugs. Full adherence was reported in 74% of questionnaires, did not change over time and was reported more frequently in children older than 10 years and those with symptomatic HIV disease. More children reporting full adherence achieved HIV RNA <400 copies/ml (e.g. at 48 weeks 79%vs. 50% reporting some nonadherence; overall P = 0.01).
Conclusion Good adherence with taking prescribed medication was associated with virologic response. Social factors were important in explaining nonadherence.

 

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