NCT01187719 (VITA 2) is a Phase 2 clinical trial of phenytoin in HIV-infection, sponsored by Radboud University Medical Center.

Who is sponsoring NCT01187719?

NCT01187719 is sponsored by Radboud University Medical Center.

What drugs are being tested in NCT01187719?

Interventions in NCT01187719: phenytoin.

What condition does NCT01187719 study?

NCT01187719 studies HIV-infection, Pregnancy, Mother to Child Transmission.

Is NCT01187719 still recruiting?

NCT01187719 is currently completed. Last updated 26 November 2020.

Last reviewed 2020-11-26 · How we verify

NCT01187719: VITA 2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Effect of Phenytoin on the Pharmacokinetics of Nevirapine and the Development of Nevirapine Resistance After a Single Dose Nevirapine (VIramune®), Which is Part of ARV Prophylaxis for PMTCT in Moshi, TAnzania, and in Lusaka, Zambia (VITA2 Trial)

Completed Phase 2 Last updated 26 November 2020

What this trial tests

Phase 2 trial testing phenytoin in HIV-infection in 66 participants. Completed in 1 September 2012.

Timeline

1 May 2010

Primary endpoint
1 June 2012

1 September 2012

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	66
Start date	1 May 2010
Primary completion	1 June 2012
Estimated completion	1 September 2012
Sites	2 locations across Tanzania, Zambia

Drugs / interventions tested

phenytoin (PHENYTOIN) — full drug profile →

Conditions studied

HIV-infection — all drugs for HIV-infection →
Pregnancy — all drugs for Pregnancy →
Mother to Child Transmission — all drugs for Mother to Child Transmission →

Sponsor

Radboud University Medical Center

Who can join

18 and older, female only, with HIV-infection or Pregnancy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

half-life time nevirapine
Time frame: untill two weeks after NVP dosing
blood samples will be taken \<30 min after delivery, 24 hours after delivery, at day 3, at day 5, at day 7 and at day 14

Sponsor's own description

The primary objective of this two-phase trial is as follows: * To determine the elimination half-life of NVP in HIV positive pregnant women receiving it as a single dose in labour in addition to the ZDV and 3TC with or without seven days phenytoin (pilot PK phase) * To determine NVP resistance in HIV positive pregnant women receiving it as a single dose in labour in addition to ZDV and 3TC with or without seven days phenytoin (main trial phase) The secondary objectives of this two-phase trial are as follows: * To determine the safety of single dose nevirapine with seven days phenytoin as a part of ARV prophylaxis for PMTCT vs. single dose of nevirapine without phenytoin as a part of ARV prophylaxis for PMTCT * To determine the HIV status of the infant * To determine the safety of the ARV prophylaxis for PMTCT with seven days of phenytoin on the newborn Hypothesis: phenytoin reduces the elimination half life of SD NVP and thereby decreases development of resistance to NVP in HIV positive pregnant Tanzanian and Zambian women.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effect of 7 days of phenytoin on the pharmacokinetics of and the development of resistance to single-dose nevirapine for perinatal HIV prevention: a randomized pilot trial.
Fillekes Q, Muro EP, Chunda C, Aitken S, et al · · 2013 · cited 1× · PMID 23864647 · DOI 10.1093/jac/dkt246

Verify or expand the search:

Other trials of phenytoin

Trials testing the same drug.

NCT03196466 — Population Pharmacokinetics of Antiepileptic in Pediatrics · completed
NCT00627575 — AED/Statin Interaction Study · Phase 1 · completed

Other Radboud University Medical Center trials

Trials by the same sponsor.

NCT07485569 — Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial · Phase 1 · not yet recruiting
NCT07514325 — MR-guided Adaptive Stereotactic Radiotherapy for Endometrial Cancer · NA · not yet recruiting
NCT07530263 — Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA) · Phase 1 · not yet recruiting
NCT07532577 — Intranasal Insulin to Prevent Intensive Care Unit Delirium · Phase 2, PHASE3 · not yet recruiting
NCT07504172 — Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01187719 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Radboud University Medical Center
Last refreshed: 26 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01187719.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing