Valacyclovir Versus Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons (ACV-VAL)
Recruitment status was Active, not recruiting
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Purpose
The purpose of this study is to determine whether treating HSV-2 with either valacyclovir or acyclovir is more effective in suppressing HIV-1 virus levels in people co-infected with HIV-1 and HSV-2.
| Condition | Intervention | Phase |
|---|---|---|
|
Herpes Simplex HIV Infection |
Drug: acyclovir Drug: Valacyclovir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-label, Crossover Trial of the Effect of High-dose Daily HSV-2 Suppressive Therapy on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons |
- Presence and quantity of the level of HIV-1 RNA in plasma of participants while on 400 mg twice daily of acyclovir versus while on 1.5 g twice daily of valacyclovir. [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
- Evaluate the safety of valacyclovir 1.5 gram orally twice daily in HIV-1 seropositive persons. [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 32 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Acyclovir
Acyclovir 400 mg orally twice daily
|
Drug: acyclovir
Acyclovir 400 mg orally, twice daily for 12 weeks
|
|
Active Comparator: Valacyclovir
Valacyclovir 1.5 g orally twice daily
|
Drug: Valacyclovir
valacyclovir 1.5 g orally, twice daily, for 12 weeks
|
Detailed Description:
Sexual transmission is responsible for the vast majority of HIV-1 infections among adults worldwide. In sub-Saharan Africa, the region hardest hit by the HIV-1 epidemic, HSV-2 prevalences of 30-50% have been seen in the general population with prevalence up to 90% in infected with HIV-1. HSV-2 is common in those with, or at risk for, HIV-1 infection, and HSV-2 reactivation increases HIV-1 acquisition and infectiousness. Recent studies have shown that suppression of HSV-2 has a sustained effect on lowering HIV-1 levels in blood plasma. New data have raised the question whether higher doses of HSV-2 suppressive therapy might be more effective at suppressing HIV-1 levels. Acyclovir and valacyclovir, chosen for use in this study, are safe and effective treatments for decreasing the frequency of HSV-2 reactivation and shedding. The standard dose of acyclovir is 400 mg twice a day. Valacyclovir, a drug that converts to acyclovir after absorption, delivers higher concentrations of acyclovir. 1.5 grams of valacyclovir, will be used to provide a higher dose of acyclovir, and will be compared with the standard dose of 400 mg twice a day of acyclovir.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV-1 seropositive
- Not on HIV-1 antiretroviral therapy nor planning to initiate antiretroviral therapy during the study period
- CD4 cell count >250 cell/µL
- Not otherwise eligible for antiretroviral therapy according to Uganda national guidelines
- Detectable HIV-1 plasma viral load
- HSV-2 seropositive
- Not intending to move out of the area for the duration of study participation.
- Able to participate in the study at the Partners in Prevention site in Thika, Kenya
Exclusion Criteria:
- Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.
- Planned use of acyclovir, valacyclovir, or famciclovir
- Use of ganciclovir, foscarnet, or cidofovir
- Known medical history of seizures
- Serum creatinine >1.5 mg/dL
- AST or ALT >3 times upper limit of normal
- Hematocrit <30 %
- Absolute neutrophil count <1000
- Platelet count <75,000
- History of thrombotic microangiopathy
- Any other condition which, in the opinion of the principal investigator, may compromise the ability to follow study procedures and complete the study
- Participation in another HIV therapeutics trial
- For women, pregnancy as confirmed by a urine pregnancy test
Contacts and Locations More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Connie Celum, MD, MPH, University of Washington |
| ClinicalTrials.gov Identifier: | NCT01026454 History of Changes |
| Other Study ID Numbers: | 37162-A |
| Study First Received: | December 2, 2009 |
| Last Updated: | February 1, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Washington:
|
HSV HIV |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Herpes Simplex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Herpesviridae Infections DNA Virus Infections Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Acyclovir Valacyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013