Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women

NCT02053142 | Completed

• 1 other identifier: CIDRZ 1208/IRB12-0390
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcers of Female Genital Organs

Keywords

Pharmacokinetics; Herpes simplex virus; Genital herpes ulcers

Outcome Measures

Primary Outcomes (1)

• Area under the Curve (AUC)

  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.

  0, 2, 3, 4, 6 and 8 hours post acyclovir administration

Secondary Outcomes (1)

• Time to re-epithelization and time to cessation of HSV shedding

  days 1-5, 7, 9, 11 and 13

Study Arms (3)

Part 1 PK

EXPERIMENTAL

400mg dose of acyclovir taken orally, followed by 2 ml blood plasma collection at 1,2,4,6 and 8 hours.

Drug: Acyclovir

Acyclovir

ACTIVE COMPARATOR

400 mg Acyclovir three times daily for 5 days

Drug: Acyclovir

Placebo

PLACEBO COMPARATOR

Placebo three times daily for 5 days

Drug: Placebo

Interventions

Acyclovir DRUG

Single dose of acyclovir 200mg was given for pk study

Acyclovir; Part 1 PK

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HIV negative as determined by concordant rapid testing
• HSV-2 seropositive (Focus HerpeSelect EIA \>3.4)
• At least one prior occurrence of GUD
• to 50 years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Centre for Infectious Disease Research in Zambia

Lusaka, Zambia

Location

Related Publications (38)

• 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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• De Miranda, P. and D. Page, Systemic absorption and pharmacokinetics of acyclovir (ZOVIRAX) when administered orally in multiple doses of 600 mg to immunocompromised patients with herpes infections (Protocol 12-30, Dr. R. Whitley). Burroughs Wellcome Document No. TEIN/82/0007.

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• De Miranda, P. and D. Page, Systemic absorption and pharmacokinetics of acyclovir (ZOVIRAX) when administered orally in multiple doses of 800 mg to immunocompromised patients with herpes infections (Protocol 12-30, Dr. R. Whitley) Burroughs Wellcome Document No. TEIN/83/0001.

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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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• 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.

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• 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.

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  BACKGROUND

• Paz-Bailey, G., et al. Impact of Episodic Acyclovir Therapy on Genital Ulcer Duration and HIV Shedding from Herpetic Ulcers Among Men in South Africa. in 17th International Society for STD Research Meeting. 2007. Seattle, Washington, USA.

  BACKGROUND

Related Links

• University of North Carolina website

MeSH Terms

Conditions

Herpes Simplex

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Stewart Reid, MD

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 3, 2014
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 15, 2017

Record last verified: 2014-12

Locations

ZA (1)