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| ID | Type | Description | Link |
|---|---|---|---|
| U01AI052054 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acyclovir | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acyclovir | Drug | 400mg taken orally three times daily for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Healing of Genital Lesions | To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo | Days 1-5, 7, 9, 11, 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Negative Herpes Simplex Virus (HSV) DNA PCR | To examine the time to first negative HSV DNA PCR among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo | Days 1-5, 7, 9, 11, 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Connie Celum, MD, MPH | University of Washington | Principal Investigator |
| Anna Wald, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Health and HIV Research Unit (RHRU) | Johannesburg | South Africa | ||||
| Center for Infectious Disease Research of Zambia (CIDRZ) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18572080 | Background | 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. | |
| 22330926 | Background |
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Between January and December 2009, women from Johannesburg, South Africa and Lusaka, Zambia who had previously participated in the HPTN 039 (NCT00076232) study, as well as other women in the community who presented to the research clinics with genetic ulcer disease (GUD) during the recruitment period, were invited to participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acyclovir | Acyclovir 400 mg orally three times daily |
| FG001 | Placebo | Matching placebo tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acyclovir | Acyclovir 400 mg orally three times daily |
| BG001 | Placebo | Matching placebo tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Healing of Genital Lesions | To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo | Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used. | Posted | Mean | Standard Error | Days | Days 1-5, 7, 9, 11, 13 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acyclovir | Acyclovir 400 mg orally three times daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Connie Celum, MD, MPH | University of Washington | 206-520-3824 | ccelum@uw.edu |
| ID | Term |
|---|---|
| D006558 | Herpes Genitalis |
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable 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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| matching placebo |
| Drug |
matching placebo taken orally three times daily for 5 days. |
|
| Lusaka |
| Zambia |
| 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. |
| 22183840 | Derived | Baeten JM, Reid SE, Delany-Moretlwe S, Hughes JP, Wang RS, Wilcox E, Limbada M, Akpomiemie G, Corey L, Wald A, Celum C. Clinical and virologic response to episodic acyclovir for genital ulcers among HIV-1 seronegative, herpes simplex virus type 2 seropositive African women: a randomized, placebo-controlled trial. Sex Transm Dis. 2012 Jan;39(1):21-4. doi: 10.1097/OLQ.0b013e31823b50c6. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time to First Negative Herpes Simplex Virus (HSV) DNA PCR | To examine the time to first negative HSV DNA PCR among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo | Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used. | Posted | Mean | Standard Error | Days | Days 1-5, 7, 9, 11, 13 |
|
|
|
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | Placebo | Matching placebo tablet | 0 | 27 | 0 | 27 |
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| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| 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 |