Ulcers of Female Genital OrgansNCT02053142
Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women
A study testing Acyclovir in people with Ulcers of Female Genital Organs, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Ulcers of Female Genital Organs
- What is being tested?
- Acyclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteZambia
- Study dates
- Jan 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Ulcers of Female Genital Organs
- Being tested
- Acyclovir, Placebo
- Keywords
- Pharmacokinetics, Herpes simplex virus, Genital herpes ulcers
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcyclovirDrug
Single dose of acyclovir 200mg was given for pk study
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Acyclovir |
| Acyclovir | Active comparator | 400 mg Acyclovir three times daily for 5 days Receives: Drug: Acyclovir |
| Placebo | Placebo comparator | Placebo three times daily for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: days 1-5, 7, 9, 11 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Ulcers of Female Genital OrgansStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stewart Reid, MD, Principal investigator, Centre for Infectious Disease Research in Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053142
- Sponsor's protocol ID
- CIDRZ 1208/IRB12-0390
- Status last verified
- Dec 2014
- First submitted
- 31 Jan 2014
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 6368877Nilsen AE, Aasen T, Halsos AM, Kinge BR, Tjotta EA, Wikstrom K, Fiddian AP. Efficacy of oral acyclovir in the treatment of initial and recurrent genital herpes. Lancet. 1982 Sep 11;2(8298):571-3. doi: 10.1016/s0140-6736(82)90658-4.
PubMed 6125728Celum, C., et al., HSV-2 Suppressive Therapy for Prevention of HIV Acquisition: Results of HPTN 039. The Lancet, in press.
Reitano M, Tyring S, Lang W, Thoming C, Worm AM, Borelli S, Chambers LO, Robinson JM, Corey L. Valaciclovir for the suppression of recurrent genital herpes simplex virus infection: a large-scale dose range-finding study. International Valaciclovir HSV Study Group. J Infect Dis. 1998 Sep;178(3):603-10. doi: 10.1086/515385.
PubMed 9728526Gupta R, Wald A, Krantz E, Selke S, Warren T, Vargas-Cortes M, Miller G, Corey L. Valacyclovir and acyclovir for suppression of shedding of herpes simplex virus in the genital tract. J Infect Dis. 2004 Oct 15;190(8):1374-81. doi: 10.1086/424519. Epub 2004 Sep 20.
PubMed 15378428Watson-Jones D, Weiss HA, Rusizoka M, Changalucha J, Baisley K, Mugeye K, Tanton C, Ross D, Everett D, Clayton T, Balira R, Knight L, Hambleton I, Le Goff J, Belec L, Hayes R; HSV trial team; Steering and Data Monitoring Committees. Effect of herpes simplex suppression on incidence of HIV among women in Tanzania. N Engl J Med. 2008 Apr 10;358(15):1560-71. doi: 10.1056/NEJMoa0800260. Epub 2008 Mar 12.
PubMed 18337596Blum, M., et al., The bioavailability and pharmacokinetics of ZOVIRAX 200 mg capsules vs solution in normal volunteers at risk of developing herpes simplex virus infections (Protocol P12-83). Burroughs Wellcome Document No. TEIN/82/0001.
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.
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.
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.
Amini H, Javan M, Gazerani P, Ghaffari A, Ahmadiani A. Lack of bioequivalence between two aciclovir tablets in healthy subjects. Clin Drug Investig. 2008;28(1):47-53. doi: 10.2165/00044011-200828010-00006.
PubMed 18081360Bahrami 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.
PubMed 15664366Palma-Aguirre JA, Absalon-Reyes JA, Novoa-Heckel G, de Lago A, Oliva I, Rodriguez Z, Gonzalez-de la Parra M, Burke-Fraga V, Namur S. Bioavailability of two oral suspension and two oral tablet formulations of acyclovir 400 mg: two single-dose, open-label, randomized, two-period crossover comparisons in healthy Mexican adult subjects. Clin Ther. 2007 Jun;29(6):1146-52. doi: 10.1016/j.clinthera.2007.06.007.
PubMed 17692728Vergin H, Kikuta C, Mascher H, Metz R. Pharmacokinetics and bioavailability of different formulations of aciclovir. Arzneimittelforschung. 1995 Apr;45(4):508-15.
PubMed 7779152Landowski 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.
PubMed 12750437
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women
- ClinicalTrials.gov ID
- NCT02053142
- Acronym / sponsor ID
- CIDRZ 1208/IRB12-0390
- Conditions
- Ulcers of Female Genital Organs
- Keywords
- Pharmacokinetics, Herpes simplex virus, Genital herpes ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 PK | Experimental | Drug: Acyclovir400mg dose of acyclovir taken orally, followed by 2 ml blood plasma collection at 1,2,4,6 and 8 hours. |
| Acyclovir | Active comparator | Drug: Acyclovir400 mg Acyclovir three times daily for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo three times daily for 5 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcyclovirSingle dose of acyclovir 200mg was given for pk study | Drug | Acyclovir, Part 1 PK |
| Placebo | Drug | Placebo |
Primary outcome
Area under the Curve (AUC)
Time frame: 0, 2, 3, 4, 6 and 8 hours post acyclovir administration
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.
1 secondary outcome
Time to re-epithelization and time to cessation of HSV shedding
Time frame: days 1-5, 7, 9, 11 and 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Background: PubMed 6368877Reichman 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.
- Background: PubMed 6125728Nilsen AE, Aasen T, Halsos AM, Kinge BR, Tjotta EA, Wikstrom K, Fiddian AP. Efficacy of oral acyclovir in the treatment of initial and recurrent genital herpes. Lancet. 1982 Sep 11;2(8298):571-3. doi: 10.1016/s0140-6736(82)90658-4.
- BackgroundCelum, C., et al., HSV-2 Suppressive Therapy for Prevention of HIV Acquisition: Results of HPTN 039. The Lancet, in press.
- Background: PubMed 9728526Reitano M, Tyring S, Lang W, Thoming C, Worm AM, Borelli S, Chambers LO, Robinson JM, Corey L. Valaciclovir for the suppression of recurrent genital herpes simplex virus infection: a large-scale dose range-finding study. International Valaciclovir HSV Study Group. J Infect Dis. 1998 Sep;178(3):603-10. doi: 10.1086/515385.
- Background: PubMed 15378428Gupta R, Wald A, Krantz E, Selke S, Warren T, Vargas-Cortes M, Miller G, Corey L. Valacyclovir and acyclovir for suppression of shedding of herpes simplex virus in the genital tract. J Infect Dis. 2004 Oct 15;190(8):1374-81. doi: 10.1086/424519. Epub 2004 Sep 20.
- Background: PubMed 18337596Watson-Jones D, Weiss HA, Rusizoka M, Changalucha J, Baisley K, Mugeye K, Tanton C, Ross D, Everett D, Clayton T, Balira R, Knight L, Hambleton I, Le Goff J, Belec L, Hayes R; HSV trial team; Steering and Data Monitoring Committees. Effect of herpes simplex suppression on incidence of HIV among women in Tanzania. N Engl J Med. 2008 Apr 10;358(15):1560-71. doi: 10.1056/NEJMoa0800260. Epub 2008 Mar 12.
- BackgroundBlum, M., et al., The bioavailability and pharmacokinetics of ZOVIRAX 200 mg capsules vs solution in normal volunteers at risk of developing herpes simplex virus infections (Protocol P12-83). Burroughs Wellcome Document No. TEIN/82/0001.
- BackgroundDe 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.
- BackgroundDe 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.
- BackgroundBlum, 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.
- Background: PubMed 18081360Amini H, Javan M, Gazerani P, Ghaffari A, Ahmadiani A. Lack of bioequivalence between two aciclovir tablets in healthy subjects. Clin Drug Investig. 2008;28(1):47-53. doi: 10.2165/00044011-200828010-00006.
- Background: PubMed 15664366Bahrami 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.
- University of North Carolina websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stewart Reid, MD principal investigator
Centre for Infectious Disease Research in Zambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acyclovir in people with Ulcers of Female Genital Organs, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the Curve (AUC) (time frame: 0, 2, 3, 4, 6 and 8 hours post acyclovir administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02053142, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.