Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Washington GlaxoSmithKline |
---|---|
Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00527618 |
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.
Condition | Intervention | Phase |
---|---|---|
Genital Herpes HIV Infections |
Drug: valacyclovir Drug: acyclovir |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 38 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
valacyclovir 1 gram orally twice daily
|
Drug: valacyclovir
1 gram orally twice daily
|
2: Active Comparator
acyclovir 400 mg orally twice daily
|
Drug: acyclovir
400 mg orally twice daily
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jared Baeten, MD, PhD | 206-720-4340 | jbaeten@u.washington.edu |
United States, Washington | |
University of Washington Virology Research Clinic | Recruiting |
Seattle, Washington, United States, 98122 | |
Contact 206-720-4340 vrc@u.washington.edu |
Principal Investigator: | Jared Baeten, MD, PhD | University of Washington |
Study Director: | Anna Wald, MD, MPH | University of Washington |
Responsible Party: | University of Washington ( Jared Baeten ) |
Study ID Numbers: | 31203, GSK VAL111009 - VAL140 |
Study First Received: | September 7, 2007 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00527618 |
Health Authority: | United States: Institutional Review Board |
Herpes Simplex Virus 2 Human Immunodeficiency Virus Treatment Naive |
Herpes Simplex Sexually Transmitted Diseases, Viral Skin Diseases Herpes Genitalis Acquired Immunodeficiency Syndrome Genital Diseases, Male Immunologic Deficiency Syndromes Herpesviridae Infections Valacyclovir |
Virus Diseases Genital Diseases, Female Skin Diseases, Infectious Acyclovir HIV Infections Sexually Transmitted Diseases DNA Virus Infections Retroviridae Infections |
Skin Diseases, Viral Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases |
Therapeutic Uses Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |