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March 1, 1995The Journal of Infectious Diseases

High-Dose Nevirapine: Safety, Pharmacokinetics, And Antiviral Effect In Patients With Human Immunodeficiency Virus Infection

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Why the study?

Does high-dose nevirapine (400 mg/day) produce sustained antiviral activity and acceptable safety in patients with HIV infection?

Population

21 patients with Human Immunodeficiency Virus (HIV) infection

Design

Cohort

Follow-up

12 weeks

Authors

DHDiane V. HavlirUniversity of California, San FranciscoSCSarah H. CheesemanLeeds Teaching Hospitals NHS TrustMMMark P. McLaughlinWellStar Health System

Discussion

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Implication

Rapid resistance limits nevirapine monotherapy durability; leaves open optimal combinations to sustain HIV suppression.

Structured PICO

Does high-dose nevirapine (400 mg/day) produce sustained antiviral activity and acceptable safety in patients with HIV infection?

P
Population
21 patients with Human Immunodeficiency Virus (HIV) infection
I
Intervention
Nevirapine 400 mg/day
O
Outcome
Safety, pharmacokinetics, and antiviral activity (reduction in immune complex-dissociated p24 antigen and serum HIV RNA concentration)surrogate

High-dose nevirapine (400 mg/day) produces initial antiviral activity but leads to universal selection of resistant virus by 12 weeks and significant dose-limiting rash.

Cite This Study

Havlir et al. (1995) studied this question.

synapsesocial.com/papers/6a7e5666a7b8a675434c448fhttps://doi.org/10.1093/infdis/171.3.537
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1The Efficacy of Azidothymidine (AZT) in the Treatment of Patients with AIDS and AIDS-Related Complex1987 · 2,995 citations
  2. 2Pharmacokinetics of nevirapine: initial single-rising-dose study in humans1993 · 102 citations
  3. 3Nevirapine resistance mutations of human immunodeficiency virus type 1 selected during therapy1994 · 579 citations
  4. 4Identification of the human immunodeficiency virus reverse transcriptase residues that contribute to the activity of diverse nonnucleoside inhibitors1992 · 75 citations
  5. 5Human immunodeficiency virus type 1 mutants resistant to nonnucleoside inhibitors of reverse transcriptase arise in tissue culture.1991 · 394 citations