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Infant nevirapine
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks HIV reverse transcriptase to prevent viral replication in infants.
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks HIV reverse transcriptase to prevent viral replication in infants. Used for Prevention of mother-to-child transmission of HIV in infants, HIV-1 infection in infants and children.
At a glance
| Generic name | Infant nevirapine |
|---|---|
| Also known as | Viramune (Nevirapine) suspension 50mg/5ml |
| Sponsor | Centers for Disease Control and Prevention |
| Drug class | Non-nucleoside reverse transcriptase inhibitor (NNRTI) |
| Target | HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
Nevirapine binds directly to HIV reverse transcriptase and inhibits its enzymatic activity, preventing the conversion of viral RNA to DNA and thus blocking HIV replication. In infants, particularly those exposed perinatally, nevirapine is used as part of antiretroviral therapy to suppress viral load and prevent mother-to-child transmission of HIV.
Approved indications
- Prevention of mother-to-child transmission of HIV in infants
- HIV-1 infection in infants and children
Common side effects
- Rash
- Hepatotoxicity
- Stevens-Johnson syndrome
- Gastrointestinal disturbances
Key clinical trials
- Early Infant HIV Treatment in Botswana (PHASE2, PHASE3)
- Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission (PHASE1, PHASE2)
- ARVs to Prevent Breastmilk HIV:Viral and Immune Responses (PHASE2)
- Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding (PHASE3)
- Antiretroviral Regime for Viral Eradication in Newborns (PHASE4)
- Study of HIV-Infected and Uninfected Pregnant Woman/Child Dyads in Gaborone, Botswana (PHASE4)
- Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries (PHASE3)
- Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Infant nevirapine CI brief — competitive landscape report
- Infant nevirapine updates RSS · CI watch RSS
- Centers for Disease Control and Prevention portfolio CI