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701. Results of the economic evaluation of the FIRST study: a multinational prospective economic evaluation

for epoprostenol therapy at the time of writing. Costs of concomitant medications were also excluded. Statistical analysis of costs 95% confidence intervals (CI) were generated around the projection of expected costs and QALMs had all patients been followed for 12 months using the nonparametric bootstrap procedure. Due to the potentially skewed nature of costs, an additional analysis to test for differences was performed on the log of total costs. Indirect Costs Not stated. Currency US dollars ($). Sensitivity (...) of whom 239 (51%) received epoprostenol/usual care and 232 (49%) received usual care alone. The two groups were similar except for the proportion of patients receiving assistance in daily living from someone other than a friend or home health aide. Study design This was a multinational randomised controlled trial. The enrolment into the trial was on a rolling admission basis, hence the patients' follow-up time ranged from a few weeks to 18 months. In total, data for 1,932 patient months were collected

1996 NHS Economic Evaluation Database.

702. Baraclude (entecavir)

process F, process A and B used different reagents, solvents and intermediates, while process C used the same sequence and the same intermediates but with some minor difference regarding the reagents and the working procedures. No significant differences between lots obtained by the different processes have been noted, especially in term of impurity profile. • Specification The active substance specification includes tests for appearance, colour, identity (IR, HPLC), optical rotation, assay (HPLC (...) ), impurities (HPLC) and water content. The HPLC method used to control the impurities allows detection of the diastereomeric impurities that may be present in the active. Concerning the enantiomeric purity of entecavir as well as residual solvents, heavy metals and sulphated ash, it has been found acceptable not to test them based on the justifications and data provided. Impurity limits in the specification are justified by toxicology studies. 3/55 ©EMEA 2006 Batch analysis data provided confirm

2007 European Medicines Agency - EPARs

703. Aptivus (tipranavir)

/10 (70.0) From the combined RESIST studies, the baseline genotypic testing demonstrated that the most common key codon mutation pattern observed in patients in the two arms were: • 82 and 90, n=252; • 84 and 90, n=209; • 84 only, n=184; • 33 and 82, n=170; • 90 only, n=97. The baseline combination of 82 and 84 was observed in 62 patients. 19/37 ? EMEA 2005 Looking at the primary endpoint treatment response (confirmed 1 log drop in viral load from baseline) for a variety of patterns in baseline (...) /200 TPV/r 750/200 All TPV/r Type of Analysis N Median N Median N Median ? 2 (p-value) a LOCF 73 -0.85 b 72 -0.93 b 71 -1.18 b 2.913 (0.2330) OT 70 -0.87 b 68 -0.96 b 66 -1.19 b 2.863 (0.2389) a Chi-square statistic and significance value from the Kruskal-Wallis test with 2 df. b p 1 log 10 reduction from baseline and the proportion of patients with viral load 1 000 copies/ml at screening, any CD4+ cell count). An amendment was made to the protocol to allow with highly protease inhibitor resistant

2005 European Medicines Agency - EPARs

704. Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)

: Baseline up to dosing change (> 25 weeks) ] Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline. Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks]) [ Time Frame: From dosing change to end of follow-up (Week 73)(up to 48 weeks) ] Log drop at baseline of dosing change = difference of log viral loads (...) is detectable, BOC 400 mg TID will be added for 36 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period. Drug: Boceprevir (BOC) 100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID Other Name: SCH 503034 Biological: PegIntron (PEG) 1.5 mcg/kg weekly subcutaneously Drug: Ribavirin (RBV) 200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight [weight-based dosing

2005 Clinical Trials

705. A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study

antiretroviral therapy (ART), in human immunodeficiency virus Type 1 (HIV-1) infected participants. Condition or disease Intervention/treatment Phase Human Immunodeficiency Virus Type 1 Drug: Etravirine (ETR) Drug: Nucleotide reverse transcriptase inhibitors (NRTIs) Drug: Protease inhibitors (PIs) Drug: Enfuvirtide (ENF) Phase 2 Detailed Description: This is a Phase II, open-label (all people know the identity of the intervention), roll-over study (participants may go ahead and participate in another (...) will continue to receive ETR until they are no longer benefitted or this medication becomes commercially available. Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 211 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title

2005 Clinical Trials

706. High frequency of rapid immunological progression in African infants infected in the era of perinatal HIV prophylaxis. (PubMed)

High frequency of rapid immunological progression in African infants infected in the era of perinatal HIV prophylaxis. To determine the natural history of HIV infection following peripartum single-dose nevirapine (sd-NVP) prophylaxis in a resource-limited country, and to assess implications for antiretroviral therapy (ART) roll-out programmes.Infants of HIV-infected mothers in KwaZulu-Natal, South Africa, were tested on days 1 and 28 to detect intrauterine (IU) and intrapartum (IP) infection (...) 000 copies/ml; P < 0.001). Median viral load at birth in IU-infected infants (155 000 copies/ml) fell 1.4 log to 6510 copies/ml by day 5 and was beneath the detection limit using dried blood spot analysis in 38% of infants. CD4 cell% declined rapidly, to < or = 20% in 70% and < or = 25% in 85% [current World Health Organization (WHO) criteria for initiating ART] of infants by 6 months.MTCT was reduced by sd-NVP through an effect on IP transmission. Where MTCT occurred despite NVP, two-thirds

2007 AIDS Controlled trial quality: uncertain

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