NEWS HIGHLIGHTS
Published Studies Related to Viracept (Nelfinavir)
Complex drug interactions of HIV protease inhibitors 1: inactivation, induction, and inhibition of cytochrome P450 3A by ritonavir or nelfinavir. [2011.06]
Conflicting drug-drug interaction (DDI) studies with the HIV protease inhibitors (PIs) suggest net induction or inhibition of intestinal or hepatic CYP3A. As part of a larger DDI study in healthy volunteers, we determined the effect of extended administration of two PIs, ritonavir (RTV) or nelfinavir (NFV), or the induction-positive control rifampin on intestinal and hepatic CYP3A activity as measured by midazolam (MDZ) disposition after a 14-day treatment with the PI in either staggered (MDZ approximately 12 h after PI) or simultaneous (MDZ and PI coadministered) manner...
Influence of CYP2C19 polymorphism on the pharmacokinetics of nelfinavir and its active metabolite. [2009.11]
AIMS: This study reports the pharmacokinetics of nelfinavir, its active metabolite, M8, and active moiety (nelfinavir + M8) in volunteers genotyped for CYP2C19 as extensive metabolizer (*1*1; n = 38), heterozygous poor metabolizer (PM) (*1*2; n = 22) and homozygous PM (*2*2; n = 6)... CONCLUSIONS: Mutation in CYP2C19 increased the systemic exposure of nelfinavir and reduced the exposure of M8. No significant differences were noted among the heterozygous (*1*2) and homozygous (*2*2) PMs. These changes are not considered to be clinically relevant and hence the use of nelfinavir does not require prior assessment of CYP2C19 genotype.
Pharmacokinetic study and comparative bioavailability of two nelfinavir tablet formulations in Iranian healthy volunteers after a low-dose administration. [2009.07]
The objective of this study is to evaluate pharmacokinetic parameters, bioavailability of a potent HIV protease inhibitor, nelfinavir mesylate (NFV), following a single oral administration of 2 tablet formulations. A randomized, 2-way, crossover, bioequivalence study was conducted in 24 healthy male volunteers to compare 2 brands of nelfinavir 250 mg tablets, Nelfabiovir (Bakhtar Bioshimi, Iran) as test and Viracept (Roche, Germany) as reference product...
Effects of standard and supratherapeutic doses of nelfinavir on cardiac repolarization: a thorough QT study. [2009.03]
This was a randomized, 4-way crossover, third-party-blinded study in 68 healthy subjects to assess the effect of nelfinavir on QTc interval...
Significant decrease in nelfinavir systemic exposure after omeprazole coadministration in healthy subjects. [2008.01]
STUDY OBJECTIVES: To assess the effect of omeprazole on the multiple-dose (steady-state) pharmacokinetics and safety of nelfinavir, and to evaluate the safety and tolerability of nelfinavir when administered alone and with omeprazole... CONCLUSION: The observed reduction in the systemic exposure to both nelfinavir and its active metabolite M8 after coadministration with omeprazole could result in loss of virologic control and potential emergence of drug resistance. Hence, omeprazole should not be coadministered to patients taking nelfinavir.
Clinical Trials Related to Viracept (Nelfinavir)
Nelfinavir, a Phase I/Phase II Rectal Cancer Study [Recruiting]
The aim is to study safety and activity of nelfinavir , added to standard chemoradiotherapy
in patients with locally advanced rectal cancer. Furthermore analysis of the effect of
nelfinavir combined with chemoradiation on tumour tissue will be studied
Safety Of VIRACEPT; 625 mg Administered To HIV-Infected Women During Pregnancy [Completed]
This study is an evaluation of the safety of 625 mg formulation when administered to
HIV-infected pregnant women from their second trimester through six weeks postpartum. The
study will also evaluate the pharmacokinetics of VIRACEPT
A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea [Terminated]
The purpose of this study was to determine the efficacy and safety of calcium carbonate for
the prevention of nelfinavir-associated diarrhea and to evaluate the efficacy and safety of
calcium carbonate in combination with loperamide for the treatment of nelfinavir-associated
diarrhea.
Radical Lung Radiotherapy Plus Nelfinavir [Not yet recruiting]
The aim of this clinical trial is to test whether the drug nelfinavir, which can increase
the effectiveness of radiotherapy, can be given safely at the same time as a full dose of
radiotherapy for lung cancer.
It is thought that one way that nelfinavir works is through causing changes in the blood
vessels within tumours. The status of tumour blood vessels and the blood flow through them
will be investigated during the trial using special imaging techniques. The dose of
radiation used in this trial is greater than that used in previous trials with nelfinavir in
other disease settings and the response of normal lung to the combination of nelfinavir plus
radiation is unknown. Therefore, a low dose of nelfinavir will be given to the first few
patients that participate and will be gradually increased in subsequent groups of patients
provided that no worrying side effects are identified. There is a single report of serious
side-effects in an AIDs patient who was treated with radiotherapy for lung cancer when he
was also taking nelfinavir. However, in this case nelfinavir was taken at a dose 3-fold
higher than the highest dose level to be tested in this trial. An important goal of this
trial is to select the optimum dose of nelfinavir to be used in combination with lung
radiotherapy, that can then be tested more extensively in future trials.
The radiotherapy treatment in this trial has been carefully designed to minimise the amount
of healthy lung that receives radiation. Some specialised imaging techniques will be used
during radiotherapy planning and delivery to help ensure that the lung cancer is targeted
very precisely by radiation and that normal lung is avoided as much as possible.
One effect of nelfinavir is to interfere with the function of a particular protein in cells
(called AKT). The degree to which this happens can be measured in cells from blood or tissue
samples. Therefore, another aim of the study is to investigate AKT and related proteins, to
check whether nelfinavir is having the predicted effect.
Safety Study of Nelfinavir + Cisplatin + Pelvic Radiation Therapy to Treat Cervical Cancer [Recruiting]
Nelfinavir will increase the efficacy of Cisplatin based chemo- radiation therapy for
locally advanced cervical cancer.
Reports of Suspected Viracept (Nelfinavir) Side Effects
Maternal Drugs Affecting Foetus (6),
Lipodystrophy Acquired (3),
Premature Baby (3),
Maternal Exposure During Pregnancy (3),
Maternal Exposure Timing Unspecified (3),
Ileal Atresia (3),
Foetal Exposure During Pregnancy (2),
Pulmonary Embolism (2),
Autoimmune Thyroiditis (2),
Live Birth (2), more >>
|
