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Tracking Information | |||||||||
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First Received Date † | September 7, 2007 | ||||||||
Last Updated Date | April 10, 2009 | ||||||||
Start Date † | December 2007 | ||||||||
Current Primary Outcome Measures † |
The primary endpoints are the presence and quantity of genital HSV and the level of HIV-1 RNA in plasma and genital secretions of participants while on 400 mg twice daily of acyclovir versus while on 1000 mg twice daily of valacyclovir. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00527618 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV | ||||||||
Official Title † | A Randomized, Open-Label, Crossover Trial of the Effect of Dosing of Daily HSV-2 Suppressive Therapy on HSV Reactivation and Plasma and Genital HIV-1 Levels Among HIV-1/ HSV-2 co-Infected Persons | ||||||||
Brief Summary | To compare the effect of daily valacyclovir 1 gram orally twice daily versus acyclovir 400 mg orally twice daily on the frequency of genital HSV reactivation and on plasma and genital HIV-1 levels among HSV-2/HIV-1 co-infected individuals. The investigators hypothesize that both treatments will reduce genital HSV and systemic and genital HIV-1. |
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Detailed Description | We propose to conduct a randomized, open-label, cross-over study of 38 individuals who are HIV-1 seropositive and HSV-2 seropositive. Both men and women will be recruited for the study. Participants must not be on antiretroviral therapy and must not be planning to initiate antiretroviral therapy during the anticipated study period. Participants will be randomized 1:1 to receive acyclovir 400 mg twice daily or valacyclovir 1000 mg twice daily. After 12 weeks on the initial treatment, each participant will be crossed over to the alternative treatment arm for 12 weeks. The treatment periods will be separated by a 2-week washout period. During the first four weeks of each treatment period (i.e., Weeks 1-4 and Weeks 15-18), participants will provide self-collected genital swabs daily for HSV detection. Each week during the entire study period, participants will provide plasma and genital samples for HIV-1 detection. Open-label acyclovir and valacyclovir will be used for this trial, as the primary outcome measures (genital HSV and plasma and genital HIV-1) are unlikely to be influenced by knowledge of treatment assignment. However, laboratory staff performing plasma and genital HIV-1 measurements will not be aware of treatment assignment. |
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Study Phase | Phase IV | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study | ||||||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Estimated Enrollment † | 38 | ||||||||
Estimated Completion Date | December 2010 | ||||||||
Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00527618 | ||||||||
Responsible Party | Jared Baeten, University of Washington | ||||||||
Secondary IDs †† | GSK VAL111009 - VAL140 | ||||||||
Study Sponsor † | University of Washington | ||||||||
Collaborators †† | GlaxoSmithKline | ||||||||
Investigators † |
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Information Provided By | University of Washington | ||||||||
Verification Date | April 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |