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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Acyclovir | Active Comparator | 400 mg Acyclovir three times daily for 5 days |
|
| Placebo | Placebo Comparator | Placebo three times daily for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acyclovir | Drug | Single dose of acyclovir 200mg was given for pk study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | days 1-5, 7, 9, 11 and 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stewart Reid, MD | Centre for Infectious Disease Research in Zambia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Infectious Disease Research in Zambia | Lusaka | Zambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6368877 | Background | 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. | |
| 6125728 | Background | Nilsen 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. |
| Label | URL |
|---|---|
| University of North Carolina website | View source |
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| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000212 | Acyclovir |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Placebo | Drug |
|
| Background | Celum, C., et al., HSV-2 Suppressive Therapy for Prevention of HIV Acquisition: Results of HPTN 039. The Lancet, in press. |
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| Background | 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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| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |