A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons
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| ClinicalTrials.gov Identifier: NCT00161434 |
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Recruitment Status
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Completed
First Posted
: September 12, 2005
Last Update Posted
: January 10, 2008
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Herpes Simplex HIV Infections | Drug: valacyclovir Drug: placebo | Phase 4 |
Sexually transmitted diseases and genital ulcer disease (GUD) contribute significantly to the spread of HIV, as their presence is associated with higher rates of HIV acquisition in susceptible individuals. Herpes simplex virus-2 (HSV-2) is a major cause of GUD in developed and developing countries.
The primary objective of this research study is to assess if daily valacyclovir therapy for suppression of HSV-2 reactivation is associated with a decrease in mucosal HIV shedding in individuals co-infected with both HSV-2 and HIV.
This study is a randomized, double-blind, placebo-controlled, crossover trial. Sixty men who have sex with men (MSM) will be randomized to first receive either valacyclovir, 1 gram once a day, or matching placebo for 8 weeks. After a 2-week washout period during which all participants receive placebo, subjects then switch to the other treatment for the next 8 weeks.
At screening, informed consent is obtained and individuals will have blood drawn to test antibody status to HIV and HSV and well as to monitor CD4 count and plasma HIV RNA determination. At enrollment, oral, genital, and rectal specimens are obtained and additional blood is drawn. Participants are given a two-week supply of study medication and are instructed on the technique of collecting daily home samples and completing a diary. Following enrollment, they are asked to collect daily home oral and genital samples, as well as semen samples twice a week, for the full 18 weeks of the study. Participants return to the clinic three times per week for follow-up, for collection of oral and rectal specimens, and additional study medication. Rectal Biopsy is performed at weeks 8 and 18 for those individuals that signed the additional rectal biopsy consent form.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | A Randomized, Double-Blind, Placebo Controlled Crossover Trial Using Valacyclovir to Suppress HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Persons |
| Study Start Date : | March 2003 |
| Actual Primary Completion Date : | June 2006 |
| Actual Study Completion Date : | June 2006 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Drug: valacyclovir
1 gram daily for 8 weeks
Other Name: Valtrex
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| Placebo Comparator: 2 |
Drug: placebo
matching placebo for 8 weeks
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- To assess reduction in mucosal HIV shedding associated with daily valacyclovir for suppression of HSV-2 reactivation. [ Time Frame: 18 weeks ]
- To quantify increase in rectal and pharyngeal HIV-1 shedding associated with HSV-1 and HSV-2 reactivation. To determine reduction in systemic HIV RNA during valacyclovir therapy. To evaluate reduction in inflammatory cells and HIV replication. [ Time Frame: 18 weeks ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV seropositive and HSV-2 seropositive
- MSM (men having sex with men)
- 18 years old or older
Exclusion Criteria:
- Known history of adverse reaction to acyclovir or valacyclovir
- Planned open label use of acyclovir, valacyclovir or famciclovir
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161434
| United States, Washington | |
| Virology Research Clinic | |
| Seattle, Washington, United States, 98122 | |
| Principal Investigator: | Anna Wald, MD, MPH | University of Washington |
| Responsible Party: | Anna Wald, MD, MPH, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00161434 History of Changes |
| Other Study ID Numbers: |
02-6505-A P01AI030731 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 12, 2005 Key Record Dates |
| Last Update Posted: | January 10, 2008 |
| Last Verified: | December 2007 |
Keywords provided by University of Washington:
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HIV-1 |
Additional relevant MeSH terms:
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HIV Infections Herpes Simplex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Herpesviridae Infections DNA Virus Infections Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Valacyclovir Acyclovir Antiviral Agents Anti-Infective Agents |