nevirapine and Abnormalities, Drug-Induced

nevirapine has been researched along with Abnormalities, Drug-Induced in 5 studies

Nevirapine: A potent, non-nucleoside reverse transcriptase inhibitor used in combination with nucleoside analogues for treatment of HIV INFECTIONS and AIDS.
nevirapine : A dipyridodiazepine that is 5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepine which is substituted by methyl, oxo, and cyclopropyl groups at positions 4, 6, and 11, respectively. A non-nucleoside reverse transcriptase inhibitor with activity against HIV-1, it is used in combination with other antiretrovirals for the treatment of HIV infection.

Abnormalities, Drug-Induced: Congenital abnormalities caused by medicinal substances or drugs of abuse given to or taken by the mother, or to which she is inadvertently exposed during the manufacture of such substances. The concept excludes abnormalities resulting from exposure to non-medicinal chemicals in the environment.

Research

Studies (5)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Area Under the Curve Pharmacokinetic Outcome for LPV/r. (AUC ug*hr/mL)

Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test. (NCT00109590)
Timeframe: Within 72 hours postpartum and during the first 30 days postpartum

Four (4) Hour Concentration Pharmacokinetic Outcome for LPV/r (C4hour ug/mL).

Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test. (NCT00109590)
Timeframe: Within 72 hours postpartum and during the first 30 days postpartum

Maximum Concentration Pharmacokinetic Outcome for LPV/r (Cmax ug/mL) .

Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test. (NCT00109590)
Timeframe: Within 72 hours postpartum and during the first 30 days postpartum

Median HIV-1 Viral Load at 24 Weeks Postpartum in Women

(NCT00109590)
Timeframe: at 24 weeks postpartum

Number of Women With Grade >=3 Events After Start of Study Treatment

Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading > the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities (and events of any grade that led to a change in study treatment) were included. (NCT00109590)
Timeframe: After start of study Treatment (postpartum)

Pre-dose Concentration Pharmacokinetic Outcome for LPV/r (Cpredose ug/mL).

Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test. (NCT00109590)
Timeframe: Within 72 hours postpartum and during the first 30 days postpartum

Resistance Mutations in HIV Infected Infants

Resistance mutations as identified by consensus sequencing or OLA (NCT00109590)
Timeframe: 24 weeks postpartum

The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay (OLA) in Plasma

The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis. (NCT00109590)
Timeframe: at Day 10 or Week 6 postpartum.

The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations for the Subgroup of Women With Plasma HIV RNA >= 500 Copies/ml At Entry

The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis. (NCT00109590)
Timeframe: at Day 10 or Week 6 postpartum.

The Proportion of Women Who Develop One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay in Plasma (Sampling Was Done at Days 10,21,30, and Weeks 5,6, and 8 Postpartum).

The incidence of new NVP resistance mutation in plasma HIV within 8 weeks postpartum in each randomized arm was estimated using an exact binomial confidence interval. If a resistance mutation was detected at any of the timepoints then an endpoint was met. Samples with VL <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml (e.g.missed visit), it was conservatively imputed as resistant in the primary analysis. (NCT00109590)
Timeframe: within 8 weeks postpartum.

Proportion of Women With New NVP Resistance Mutation Within 8 Weeks Postpartum Who Had a NVP Resistance Mutation Detected at 72 Weeks Postpartum.

Resistance mutations as identified by OLA in plasma samples or PBMC at 72 weeks postpartum amongst women who had new NVP resistance mutations within 8 weeks postpatrum. These results were based on the 13 women who developed a new NVP resistance mutation in the first 8 weeks postpartum. For the primary outcome measure 1, one particpant in arm A was unavailable for follow-up after week 5 and was conservatively imputed to have developed resistance mutation. (NCT00109590)
Timeframe: within 72 weeks postpartum

The Proportion of Women With Any New ZDV, ddI, or LPV/r Resistance Mutations.

(NCT00109590)
Timeframe: At Week 5 postpartum (ZDV) and at the first timepoint with viral load >=500 copies/ml after treatment discontinuation (ddI and LPV/r).

Reviews

2 reviews available for nevirapine and Abnormalities, Drug-Induced

Other Studies

3 other studies available for nevirapine and Abnormalities, Drug-Induced