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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of the study is to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily secretions.
Most people with herpes infections do not know they have the infection. HSV infections most often occur in areas in and around the mouth and genital tract. HSV Type 1 (HSV-1) usually causes "cold sores" or fever blisters and HSV Type 2 (HSV-2) usually causes lesions in the genital or rectal areas. However, HSV-1 can sometimes cause genital herpes and HSV-2 can cause oral lesions (acquired from oral-genital sex). Herpes Simplex is transmitted by contact with someone who is shedding virus in either the mouth or genital tract, usually by kissing or sexual intercourse. While contact with an active sore can cause transmission, so can contact with saliva or genital secretions that are infected, even when the person does not have an obvious sore. This is called asymptomatic shedding of HSV. Once acquired, the virus has the ability to remain inactive in the nervous system in the area of the mouth or genital region.
Persons with both HIV and HSV-2 often have shedding of both viruses. We know that persons with HSV-2 tend to have increased amounts of HIV in their blood as well. Recently, research studies have found that taking medicine daily to prevent asymptomatic HSV-2 shedding can reduce the amount of HIV found in the blood and in genital secretions. This study seeks to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir (FDA approved drug) reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily secretions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valacyclovir | Active Comparator | This is the arm taking Valacyclovir |
|
| Placebo | Placebo Comparator | This is the arm taking the placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valacyclovir | Drug | 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Herpes Simplex Virus Type 2 Recurrence | Number of recurrences of genital herpes | 24 Weeks |
| CD4 Count | CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml | 24 weeks |
| Number of Participants With an HIV Viral Load of <500 Copies/ml | Number of participants with an HIV Viral Load of <500 copies/ml at 24 weeks | 24 weeks |
| Rate of Asymptomatic HSV-2 Genital Shedding | Proportion of days on which HSV shedding was observed. This part of the study was performed in a subset of participants (N = 34). Participant collected daily genital specimens for 8 weeks starting at week 16 and continuing through week 24 of the study. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Van Wagoner, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Care Building | Birmingham | Alabama | 35294 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Valacyclovir | Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks |
| FG001 | Placebo | Placebo: Dosage: Two tablets once a day for 24 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Valacyclovir | Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks |
| BG001 | Placebo | Placebo: Dosage: Two tablets once a day for 24 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Herpes Simplex Virus Type 2 Recurrence | Number of recurrences of genital herpes | No participants reported genital herpes recurrence during the study. | Posted | Number | Recurrence | 24 Weeks |
|
|
Entire study
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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 | Valacyclovir | Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks |
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Small populations size. High level of patient withdrawal and loss to follow up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicholas Van Wagoner | University of Alabama at Birmingham | 205-934-2840 | nvw@uab.edu |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000077483 | Valacyclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 |
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| Placebo | Drug | Dosage: Two tablets once a day for 24 weeks |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Absolute CD4 (cluster of differentiation 4) Count | Mean | Full Range | cell/ml |
|
| Number with Undetectable Viral Load | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | CD4 Count | CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml | Posted | Mean | Full Range | cells/ml | 24 weeks |
|
|
|
| Primary | Number of Participants With an HIV Viral Load of <500 Copies/ml | Number of participants with an HIV Viral Load of <500 copies/ml at 24 weeks | Posted | Number | Participants | 24 weeks |
|
|
|
| Primary | Rate of Asymptomatic HSV-2 Genital Shedding | Proportion of days on which HSV shedding was observed. This part of the study was performed in a subset of participants (N = 34). Participant collected daily genital specimens for 8 weeks starting at week 16 and continuing through week 24 of the study. | Posted | Number | Proportion of days | 24 weeks | Total Number of Days Assessed | Total Number of Days Assessed |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Placebo | Placebo: Dosage: Two tablets once a day for 24 weeks | 0 | 22 | 0 | 22 | 0 | 22 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |