A Phase II, Randomized, Double-blind, Placebo-controlled Trial of Acyclovir for the Suppression of Human Immunodeficiency Virus Type 1 (HIV-1) Viral Load and Mucosal Shedding in HIV-1, Herpes Simplex Virus, Type 2 (HSV-2) Co-Infected Women
Sponsor study identifier
Secondary identifiers
REGISTRY · DAIDS ES
interventional
50
1 country
1
Study Start
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2009
Actual (reported)Study Completion
January 2009
Actual (reported)The purpose of this study is to determine whether acyclovir is effective in suppressing HIV viral load in women infected with both HIV-1 and herpes simplex virus type 2 (HSV-2) who are starting HIV treatment for the first time.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
September 1, 2006
Actual (reported)September 4, 2006
Actual (reported)January 2009
Actual (reported)January 2009
Actual (reported)Undetectable HIV plasma RNA viral load (less than 50 copies/ml)
At Week 6
Undetectable HIV plasma RNA viral load (less than 50 copies/ml)
At Week 24
Time to undetectable HIV plasma RNA viral load (less than 50 copies/ml), adjusted for baseline viral load
Throughout study
Intermittent episodes of detectable HIV plasma RNA viral load (greater than 200 copies/ml)
At Weeks 2 and 24
Positive HIV PCR test on vaginal mucosal samples
Throughout study
Participants will receive acyclovir for 24 weeks
Participants will receive acyclovir placebo for 24 weeks
800 mg tablet taken orally twice daily
800 mg placebo tablet taken orally twice daily
IMPACTA - San Miguel CIPRA Project 1 CRS
San Miguel, Lima region, 32, Peru
Posavad CM, Wald A, Kuntz S, Huang ML, Selke S, Krantz E, Corey L. Frequent reactivation of herpes simplex virus among HIV-1-infected patients treated with highly active antiretroviral therapy. J Infect Dis. 2004 Aug 15;190(4):693-6. doi: 10.1086/422755. Epub 2004 Jul 13.
Wright PW, Hoesley CJ, Squires KE, Croom-Rivers A, Weiss HL, Gnann JW Jr. A prospective study of genital herpes simplex virus type 2 infection in human immunodeficiency virus type 1 (HIV-1)-seropositive women: correlations with CD4 cell count and plasma HIV-1 RNA level. Clin Infect Dis. 2003 Jan 15;36(2):207-11. doi: 10.1086/345440. Epub 2003 Jan 6.
Aldo Lucchetti, MD
Asociación Civil Impacta Salud y Educación, Lima, Peru
Connie Celum, MD, MPH
University of Washington
First Submitted
September 1, 2006
First Posted
September 4, 2006
Study Start
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2009
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Schacker T, Zeh J, Hu H, Shaughnessy M, Corey L. Changes in plasma human immunodeficiency virus type 1 RNA associated with herpes simplex virus reactivation and suppression. J Infect Dis. 2002 Dec 15;186(12):1718-25. doi: 10.1086/345771. Epub 2002 Nov 22.
Study Completion
January 2009
Actual (reported)Last Updated
September 23, 2013
Record last verified: 2013-09
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Source: ClinicalTrials.gov.
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