Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women
13 settembre 2017 aggiornato da: University of North Carolina, Chapel Hill
Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women
This is a prospective study to evaluate the pharmacokinetics, clinical and virologic response to acyclovir episodic therapy for genital herpes ulcers in HIV negative African women.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This is a two-part study designed to measure the Area Under the Curve (AUC) from a single dose of acyclovir 400mg in 60 African HIV-negative heterosexual women who have a history of genital ulcer disease (GUD), are HSV-2 seropositive and HIV-1 seronegative.
The study will also examine the time to healing of genital lesion and duration of HSV shedding from GUD among 90 HIV negative African women who have a history of GUD and are Herpes Simplex Virus (HSV)-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir or matching placebo.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
74
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Lusaka, Zambia
- Centre for Infectious Disease Research in Zambia
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 50 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
Inclusion Criteria:
- HIV negative as determined by concordant rapid testing
- HSV-2 seropositive (Focus HerpeSelect EIA >3.4)
- At least one prior occurrence of GUD
- 18 to 50 years of age
Exclusion Criteria:
- Current use, or use within the past 7 days, of acyclovir, valacyclovir, or famciclovir
- Prior hypersensitivity and/or allergic reaction to acyclovir
- Use of probenecid, which prolongs renal excretion of acyclovir
- Current use, or use within the past 28 days, of an investigational agent
- Currently pregnant or nursing
- Currently plan to become pregnant during the next 3 months
- Currently consume, on average, more than 7 drinks of alcohol per week (for Part I)
- Current use of more than 20 cigarettes daily (for Part I)
- Any condition that in the opinion of the investigator will interfere with successful completion of all study procedures.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Part 1 PK
400mg dose of acyclovir taken orally, followed by 2 ml blood plasma collection at 1,2,4,6 and 8 hours.
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Single dose of acyclovir 200mg was given for pk study
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Comparatore attivo: Acyclovir
400 mg Acyclovir three times daily for 5 days
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Single dose of acyclovir 200mg was given for pk study
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Comparatore placebo: Placebo
Placebo three times daily for 5 days
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Area under the Curve (AUC)
Lasso di tempo: 0, 2, 3, 4, 6 and 8 hours post acyclovir administration
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Blood will be drawn for pharmacokinetic measures to determine whether there is a difference in African women vs. the existing AUC data for women and men in North America and Europe.
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0, 2, 3, 4, 6 and 8 hours post acyclovir administration
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Time to re-epithelization and time to cessation of HSV shedding
Lasso di tempo: days 1-5, 7, 9, 11 and 13
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Daily assessment of response of genital lesions over 13 days by time to healing and duration of HSV shedding during acyclovir 400mg orally three times daily versus placebo three times daily for 5 days.
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days 1-5, 7, 9, 11 and 13
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Stewart Reid, MD, Centre for Infectious Disease Research in Zambia
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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- Reichman RC, Badger GJ, Mertz GJ, Corey L, Richman DD, Connor JD, Redfield D, Savoia MC, Oxman MN, Bryson Y, et al. Treatment of recurrent genital herpes simplex infections with oral acyclovir. A controlled trial. JAMA. 1984 Apr 27;251(16):2103-7.
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- Blum, M. and S. Liao, Pharmacokinetics and relative bioavailability of acyclovir capsules (ZOVIRAX) after multiple oral doses (Interim summary of study P12-32) amendment). Burroughs Wellcome Document No. TYBH/83/0001.
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- Bahrami G, Mirzaeei Sh, Kiani A. Determination of acyclovir in human serum by high-performance liquid chromatography using liquid-liquid extraction and its application in pharmacokinetic studies. J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Feb 25;816(1-2):327-31. doi: 10.1016/j.jchromb.2004.11.038.
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- Landowski CP, Sun D, Foster DR, Menon SS, Barnett JL, Welage LS, Ramachandran C, Amidon GL. Gene expression in the human intestine and correlation with oral valacyclovir pharmacokinetic parameters. J Pharmacol Exp Ther. 2003 Aug;306(2):778-86. doi: 10.1124/jpet.103.051011. Epub 2003 May 15.
- Steingrimsdottir H, Gruber A, Palm C, Grimfors G, Kalin M, Eksborg S. Bioavailability of aciclovir after oral administration of aciclovir and its prodrug valaciclovir to patients with leukopenia after chemotherapy. Antimicrob Agents Chemother. 2000 Jan;44(1):207-9. doi: 10.1128/AAC.44.1.207-209.2000.
- Frenkel LM, Brown ZA, Bryson YJ, Corey L, Unadkat JD, Hensleigh PA, Arvin AM, Prober CG, Connor JD. Pharmacokinetics of acyclovir in the term human pregnancy and neonate. Am J Obstet Gynecol. 1991 Feb;164(2):569-76. doi: 10.1016/s0002-9378(11)80023-2.
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- Spruance SL, Jones TM, Blatter MM, Vargas-Cortes M, Barber J, Hill J, Goldstein D, Schultz M. High-dose, short-duration, early valacyclovir therapy for episodic treatment of cold sores: results of two randomized, placebo-controlled, multicenter studies. Antimicrob Agents Chemother. 2003 Mar;47(3):1072-80. doi: 10.1128/AAC.47.3.1072-1080.2003.
- Bodsworth NJ, Crooks RJ, Borelli S, Vejlsgaard G, Paavonen J, Worm AM, Uexkull N, Esmann J, Strand A, Ingamells AJ, Gibb A. Valaciclovir versus aciclovir in patient initiated treatment of recurrent genital herpes: a randomised, double blind clinical trial. International Valaciclovir HSV Study Group. Genitourin Med. 1997 Apr;73(2):110-6. doi: 10.1136/sti.73.2.110.
- Sacks SL, Aoki FY, Diaz-Mitoma F, Sellors J, Shafran SD. Patient-initiated, twice-daily oral famciclovir for early recurrent genital herpes. A randomized, double-blind multicenter trial. Canadian Famciclovir Study Group. JAMA. 1996 Jul 3;276(1):44-9.
- Spruance SL, Tyring SK, DeGregorio B, Miller C, Beutner K. A large-scale, placebo-controlled, dose-ranging trial of peroral valaciclovir for episodic treatment of recurrent herpes genitalis. Valaciclovir HSV Study Group. Arch Intern Med. 1996 Aug 12-26;156(15):1729-35.
- Aoki FY, Tyring S, Diaz-Mitoma F, Gross G, Gao J, Hamed K. Single-day, patient-initiated famciclovir therapy for recurrent genital herpes: a randomized, double-blind, placebo-controlled trial. Clin Infect Dis. 2006 Jan 1;42(1):8-13. doi: 10.1086/498521. Epub 2005 Nov 23. Erratum In: Clin Infect Dis. 2006 Feb 15;42(4):588.
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Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2009
Completamento primario (Effettivo)
1 dicembre 2009
Completamento dello studio (Effettivo)
1 dicembre 2009
Date di iscrizione allo studio
Primo inviato
31 gennaio 2014
Primo inviato che soddisfa i criteri di controllo qualità
31 gennaio 2014
Primo Inserito (Stima)
3 febbraio 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 settembre 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 settembre 2017
Ultimo verificato
1 dicembre 2014
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CIDRZ 1208/IRB12-0390
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .