HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding

NCT00530777 | Completed Phase 2 Results DMC

• 3 other identifiers: 3246207-7306-A01R03HD057773
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we will determine whether treating pregnant and breastfeeding women co-infected with human immunodeficiency virus type 1 (HIV-1) and herpes simplex virus type 2 (HSV-2) with daily valacyclovir will reduce HIV-1 levels in plasma, genital, and breast milk and will decrease the risk of mother-to-child HIV-1 transmission (MTCT).

Conditions

HIV Infections; Herpes Simplex

Keywords

Disease Transmission, Vertical; valacyclovir; Randomized Controlled Trials; HIV; herpes; Herpesvirus 2, Human; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation

  Calculated as log10 plasma viral load at 34 weeks gestation - log10 plasma viral load at 38 weeks gestation

  4 weeks

Secondary Outcomes (1)

• Vertical HIV-1 Transmission

  1 year postpartum

Study Arms (2)

1

EXPERIMENTAL

500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum

Drug: valacyclovir

2

PLACEBO COMPARATOR

oral placebo twice daily from 34 weeks gestation to 1 year postpartum

Drug: placebo

Interventions

valacyclovir DRUG

500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum

Also known as: Valtrex

1

placebo DRUG

oral placebo twice daily from 34 weeks gestation to 1 year postpartum

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 seropositive
• HSV-2 seropositive
• Plans to deliver in Nairobi
• Resides and plans to remain in Nairobi for 12 months postpartum
• years of age or older
• CD4 count\>250 cells/μl

You may not qualify if:

• indication for highly active antiretroviral therapy (e.g., WHO stage III or IV)
• hypersensitivity to valacyclovir or acyclovir

Sponsors & Collaborators

• University of Washington: lead
• Royalty Research Fund - University of Washington: collaborator
• Puget Sound Partners for Global Health: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Mathare North City Clinic

Nairobi, Kenya

Location

Related Publications (25)

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  BACKGROUND

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  PMID: 10432324 BACKGROUND

• Shaffer N, Roongpisuthipong A, Siriwasin W, Chotpitayasunondh T, Chearskul S, Young NL, Parekh B, Mock PA, Bhadrakom C, Chinayon P, Kalish ML, Phillips SK, Granade TC, Subbarao S, Weniger BG, Mastro TD. Maternal virus load and perinatal human immunodeficiency virus type 1 subtype E transmission, Thailand. Bangkok Collaborative Perinatal HIV Transmission Study Group. J Infect Dis. 1999 Mar;179(3):590-9. doi: 10.1086/314641.

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• Roxby AC, Atkinson C, Asbjornsdottir K, Farquhar C, Kiarie JN, Drake AL, Wald A, Boeckh M, Richardson B, Emery V, John-Stewart G, Slyker JA. Maternal valacyclovir and infant cytomegalovirus acquisition: a randomized controlled trial among HIV-infected women. PLoS One. 2014 Feb 4;9(2):e87855. doi: 10.1371/journal.pone.0087855. eCollection 2014.

  PMID: 24504006 DERIVED

• Roxby AC, Liu AY, Drake AL, Kiarie JN, Richardson B, Lohman-Payne BL, John-Stewart GC, Wald A, De Rosa S, Farquhar C. Short communication: T cell activation in HIV-1/herpes simplex virus-2-coinfected Kenyan women receiving valacyclovir. AIDS Res Hum Retroviruses. 2013 Jan;29(1):94-8. doi: 10.1089/AID.2012.0071. Epub 2012 Sep 4.

  PMID: 22852760 DERIVED

• Drake AL, Roxby AC, Kiarie J, Richardson BA, Wald A, John-Stewart G, Farquhar C. Infant safety during and after maternal valacyclovir therapy in conjunction with antiretroviral HIV-1 prophylaxis in a randomized clinical trial. PLoS One. 2012;7(4):e34635. doi: 10.1371/journal.pone.0034635. Epub 2012 Apr 11.

  PMID: 22509337 DERIVED

• Drake AL, Roxby AC, Ongecha-Owuor F, Kiarie J, John-Stewart G, Wald A, Richardson BA, Hitti J, Overbaugh J, Emery S, Farquhar C. Valacyclovir suppressive therapy reduces plasma and breast milk HIV-1 RNA levels during pregnancy and postpartum: a randomized trial. J Infect Dis. 2012 Feb 1;205(3):366-75. doi: 10.1093/infdis/jir766. Epub 2011 Dec 6.

  PMID: 22147786 DERIVED

MeSH Terms

Conditions

HIV Infections; Herpes Simplex

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Herpesviridae Infections; DNA Virus Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Unable to evaluate the effect of valacyclovir on mother-to-child HIV transmission (MTCT) or on change in HIV-1 RNA among women eligible for highly active antiretroviral therapy (HAART); lack power to detect association between treatment and MTCT.

Results Point of Contact

• Title: Dr. Carey Farquhar
• Organization: University of Washington

cfarq@uw.edu

206-543-4278

Study Officials

• Carey Farquhar, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: April 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 19, 2018
• Results First Posted: April 18, 2012

Record last verified: 2018-11

Locations

KE (1)