HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1, HSV-2 co-Infected Men.
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Purpose
Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The evidence suggests that that HSV is an important cofactor in HIV transmission.
The trial's purpose is to assess the reduction in HIV shedding associated with valacyclovir for suppression of HSV-2 reactivation.
This proof-of-concept, randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected men, assessed the effects of daily valacyclovir on HIV-1 levels in the plasma and rectal mucosa secretions.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection Herpes Simplex Sexually Transmitted Diseases |
Drug: valacyclovir Drug: matching placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Valacyclovir for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Men Who Have Sex With Men (MSM). |
- Reduction in anogenital HIV-1 shedding with suppression of HSV-2 reactivation. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Evaluate HSV-2 suppression with decreased plasma HIV RNA levels [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Assess the effect of daily valacyclovir on pharyngeal shedding in HSV-1 seropositive individuals [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Determine the temporal pattern of HIV shedding in the rectum, pharynx and semen with respect to mucosal HSV-1 and HSV-2 reactivation; Determine HSV-2 suppression and HIV replication within rectal mucosa. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | August 2003 |
| Study Completion Date: | July 2004 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: valacyclovir
500 mg twice-daily oral
|
| Placebo Comparator: 2 |
Drug: matching placebo
twice daily as per experimental drug
|
Detailed Description:
Herpes simplex virus type 2 (HSV-2) is common among HIV infected persons. HSV-2 reactivation is associated with increased plasma and genital HIV-1 levels, and in vitro, HSV-2 upregulates HIV transcription.
The trial assessed whether HSV-2 suppression reduces rectal and plasma HIV-1 levels in HIV-1, HSV-2 co-infected men who have sex with men (MSM).
Conducted in Lima Peru, 20 antiretroviral naive HIV-1 and HSV-2 seropositive MSM with CD4 >200 were randomly assigned to receive valacyclovir 500 mg bid or placebo for 8 weeks, than a 2 week washout period, followed by the alternative regimen for 8 weeks. Men collected daily home anogenital swabs for HSV DNA PCR, had three weekly anoscopy procedures for collection of rectal mucosal secretions for HIV-1 RNA, HSV DNA, and weekly plasma HIV-1 RNA by PCR. Outcomes were plasma and rectal HIV-1 levels by study arm.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Greater than 18 years old,
- Documented HIV-1 seropositive,
- CD4 count greater than 200,
- Not on HIV antiretroviral therapy,
- HSV-2 seropositive as determined by Focus EIA (IN >3.5)
- Not intending to move out of the area for the duration of study participation.
- Willing and able to:provide independent written informed consent;undergo clinical evaluations;take study drug as directed;adhere to follow-up schedule.
- Bacterial STDs (symptomatic STD syndromes or laboratory-confirmed asymptomatic gonorrhea and syphilis) are treated within two weeks of study enrollment and random assignment.
Exclusion Criteria:
MSM who meet any of the following criteria are not eligible for this study:
- Known history of adverse reaction to valacyclovir, acyclovir or famciclovir;
- Planned open label use of acyclovir, valacyclovir, or famciclovir
- Known medical history of seizures
- Known renal failure, serum creatinine >2.0mg/dl
- Hematocrit < 30 %
Contacts and Locations| Peru | |
| Asociacion Civil Impacta Salud y Educacion | |
| Lima, Peru | |
| Principal Investigator: | Connie Celum, MD, MPH | University of Washington |
More Information
No publications provided by University of Washington
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: | NCT00378976 History of Changes |
| Other Study ID Numbers: | 02-3200-A-05, AI277S7;AI38858;AI30731 |
| Study First Received: | September 19, 2006 |
| Last Updated: | December 11, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Washington:
|
HIV infection HIV shedding HSV suppression Co-infected |
MSM Reactivation Valacyclovir |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Herpes Simplex Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Herpesviridae Infections |
DNA Virus Infections Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Infection Genital Diseases, Male Genital Diseases, Female Valacyclovir Acyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013