An interventional study of Valacyclovir and Placebo in HIV and HIV Infections, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-13.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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.
4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.
This study's enrollment of 103 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.
Browse Recurrence studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This is the arm taking Valacyclovir
Drug: Valacyclovir
This is the arm taking the placebo
Drug: Placebo
500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
Also known as: There are no other names
Dosage: Two tablets once a day for 24 weeks
Also known as: There are no other names
Herpes Simplex Virus Type 2 Recurrence
Number of recurrences of genital herpes
Time frame: 24 Weeks
CD4 Count
CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml
Time frame: 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
Time frame: 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.
Time frame: 24 weeks
| Milestone | Valacyclovir | Placebo |
|---|---|---|
| Started | 69 | 34 |
| Completed | 45 | 22 |
| Not completed | 24 | 12 |
Number of recurrences of genital herpes
| Recurrence | Valacyclovir | Placebo |
|---|---|---|
| Herpes Simplex Virus Type 2 Recurrence | 0 | 0 |
CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml
| cells/ml | Valacyclovir | Placebo |
|---|---|---|
| CD4 Count | 536 (191 to 1112) | 627.5 (199 to 1268) |
Number of participants with an HIV Viral Load of \<500 copies/ml at 24 weeks
| Participants | Valacyclovir | Placebo |
|---|---|---|
| Number of Participants With an HIV Viral Load of <500 Copies/ml | 38 | 20 |
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.
| Proportion of days | Valacyclovir | Placebo |
|---|---|---|
| Rate of Asymptomatic HSV-2 Genital Shedding | 0.0009 | 0.0001 |
Collected over Entire study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Valacyclovir | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
| Placebo | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Continuous(years) | Valacyclovir | Placebo | Total |
|---|---|---|---|
| Mean | 45 (23 to 68) | 43 (27 to 61) | 45 (23 to 68) |
| Sex: Female, Male(Participants) | Valacyclovir | Placebo | Total |
|---|---|---|---|
| Female | 8 | 1 | 9 |
| Male | 37 | 21 | 58 |
| Ethnicity (NIH/OMB)(Participants) | Valacyclovir | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 45 | 22 | 67 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Valacyclovir | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 25 | 9 | 34 |
| White | 20 | 13 | 33 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Valacyclovir | Placebo | Total |
|---|---|---|---|
| United States | 45 | 22 | 67 |
| Absolute CD4 (cluster of differentiation 4) Count(cell/ml) | Valacyclovir | Placebo | Total |
|---|---|---|---|
| Mean | 528 (165 to 1135) | 693 (198 to 1272) | 582 (165 to 1272) |
| Number with Undetectable Viral Load(participants) | Valacyclovir | Placebo | Total |
|---|---|---|---|
| Number | 40 | 19 | 59 |
Plan to share: No
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University of Alabama at Birmingham