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GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women

Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Genital Herpes

Intervention: acyclovir (Drug); matching placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Washington

Official(s) and/or principal investigator(s):
Connie Celum, MD, MPH, Principal Investigator, Affiliation: University of Washington
Anna Wald, MD, MPH, Principal Investigator, Affiliation: University of Washington

Summary

To examine the time to healing of genital lesion and duration of herpes simplex virus (HSV) shedding from genetic ulcer disease (GUD) among 90 HIV-negative African women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative randomized in a 2: 1 ratio to receive episodic acyclovir 400mg orally three times daily or matching placebo three times daily for 5 days and who are followed for a total of 13 days.

Clinical Details

Official title: Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Time to Healing of Genital Lesions

Secondary outcome: Time to First Negative Herpes Simplex Virus (HSV) DNA PCR

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- HIV negative as determined by concordant rapid testing

- HSV-2 seropositive (Focus HerpeSelect >3. 4)

- At least one prior occurrence of GUD

- 18-50 years of age

Exclusion Criteria:

- Current use, or use w/in past 7 days of acyclovir, valacyclovir, or famciclovir

- Prior hypersensitivity &/or allergic reaction to acyclovir

- Use of probenicid

- Current use, or use within past 28 days, of an investigational agent

- Currently pregnant or nursing

- Currently plan to become pregnant during next 3 months

- Any condition that will interfere with successful completion of study procedures

Locations and Contacts

Reproductive Health and HIV Research Unit (RHRU), Johannesburg, South Africa

Center for Infectious Disease Research of Zambia (CIDRZ), Lusaka, Zambia

Additional Information

Related publications:

Celum C, Wald A, Hughes J, Sanchez J, Reid S, Delany-Moretlwe S, Cowan F, Casapia M, Ortiz A, Fuchs J, Buchbinder S, Koblin B, Zwerski S, Rose S, Wang J, Corey L; HPTN 039 Protocol Team. Effect of aciclovir on HIV-1 acquisition in herpes simplex virus 2 seropositive women and men who have sex with men: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Jun 21;371(9630):2109-19. doi: 10.1016/S0140-6736(08)60920-4.

Lu Y, Celum C, Wald A, Baeten JM, Cowan F, Delany-Moretlwe S, Reid SE, Hughes JP, Wilcox E, Corey L, Hendrix CW. Acyclovir achieves a lower concentration in African HIV-seronegative, herpes simplex virus 2-seropositive women than in non-African populations. Antimicrob Agents Chemother. 2012 May;56(5):2777-9. doi: 10.1128/AAC.06160-11. Epub 2012 Feb 13.

Starting date: January 2009
Last updated: November 15, 2013

Page last updated: August 23, 2015

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