HPTN 039-01
Ancillary Study: Prospective Cohort Study of HPTN 039 Seroconverters: The Effect of HSV-2 Suppression on HIV-1 Viral Set Point
- HPTN 039-01 Study Summary
- HPTN 039-01-Ancillary v 1.0 (PDF)
- HPTN 039-01-Ancillary v 2.0 (PDF)
- HPTN 039
Protocol Status: Closed to Follow Up
Study Purpose: To determine the effect of HSV-2 suppression with twice-daily acyclovir during the first six months after HIV acquisition on HIV viral set point.
Study Design: Prospective multi-site cohort study.
Study Population: Women and men who have sex with men (WSM, MSM) enrolled in the randomized-controlled trial of acyclovir in the reduction of HIV acquisition (HPTN 039) who are identified as HIV-positive during follow-up.
Study Size: Estimated 81 seroconverters: 54 on placebo, 27 on acyclovir.
Study Duration: Participants who seroconvert will be followed for six months after enrollment; participants who seroconvert will be enrolled within 60 days of when the first HIV positive sample was collected for HPTN 039.
Treatment Regimen: Acyclovir 400 mg po bid or matching placebo po bid (continuation of HPTN 039 treatment).
Primary Objectives: To measure the efficacy of twice daily acycovir suppressive therapy on HIV plasma viral RNA levels during the first six months after determination of HIV infection.
Secondary Objectives: 1) To assess the effect of acyclovir suppressive therapy on CD4 counts over the first six months after infection. 2) To describe the incidence and severity of clinical HSV reactivation, as detected during visits or reported by participants, during early HIV infection.
No records returned.
| Site |
Target Enrollment |
Cumulative Enrollment |
Implementation Status |
More Info |
|---|---|---|---|---|
|
Asociacion Civil Selva Amazonica, CRS 30259 Iquitos, Peru |
N/A |
9 |
Closed to Follow Up |
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|
Asociacion Civil Impacta Salud y Educacion - Miraflores, CRS 11301 Lima, Peru |
N/A |
14 |
Enrolling |
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|
Asociacion Civil IMPACTA Salud y Education, San Miguel
Lima, Peru |
N/A |
1 |
Open to Accrual |
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|
Asociacion Civil Investigaciones Médicas en Salud - Lince, CRS 11302 Lima, Peru |
N/A |
2 |
Closed to Follow Up |
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|
Asociacion Civil Cayetano Heredia
Pucallpa, Peru |
N/A |
1 |
Closed to Follow Up |
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|
Johannesburg, South Africa |
N/A |
15 |
Closed to Follow Up |
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|
San Francisco Vaccine and Prevention Clinical Research Site 30305 San Francisco, United States |
N/A |
1 |
Enrolling |
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|
University of Washington HIV Prevention Clinical Research Site 30315 Seattle, United States |
N/A |
5 |
Enrolling |
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|
30273 Lusaka, Zambia |
N/A |
15 |
Closed to Follow Up |
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|
30290 Lusaka, Zambia |
N/A |
7 |
Closed to Follow Up |
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|
30320 Chitungwiza, Zimbabwe |
N/A |
7 |
Closed to Follow Up |
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