An Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons

This study has been withdrawn prior to enrollment.
(We were unable to enroll any participants into this study.)
Sponsor:
Information provided by (Responsible Party):
Anna Wald, University of Washington
ClinicalTrials.gov Identifier:
NCT01059084
First received: January 27, 2010
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to look at the effect of daily herpes medication, valacyclovir, on HIV levels in the blood in persons who are HIV positive and do not have oral or genital herpes.


Condition Intervention
HIV
HIV Infections
Drug: Valacyclovir

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • To evaluate plasma HIV-1 levels after treatment with valacyclovir compared to baseline HIV-1 levels before treatment. [ Time Frame: Weeks (1-10) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine frequency of reverse transcriptase drug resistant mutations in HIV-1 after exposure to valacyclovir [ Time Frame: Weeks 7 and 8 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Valacyclovir
    1000 mg tid
Detailed Description:

The purpose of this study is to look at the effect of daily herpes medication, valacyclovir on HIV levels in the blood in persons who do not have genital herpes. This will help better understand the effect that valacyclovir plays in the spread of HIV and the potential role for HIV treatment in decreasing the HIV spread.

A total of 20 individuals who are HIV-1 seropositive and HSV-1/2 seronegative will be recruited for the study. Participants must not be on antiretroviral therapy and must not be planning to initiate HIV antiretroviral therapy during the study.

Participants will be asked to come to the clinic for a total of 16 visits over the course of 10 weeks. Participants will receive valacyclovir 1000 mg three times daily for 6 weeks. During the first week, participants will return to the clinic for a total of 2 visits and will provide plasma samples for baseline HIV-1 levels. During the second week, participants will return to the clinic for a total 5 visits. At Visit 3, participants will be provided the study medication. After drug initiation, participants will be asked to return to the clinic within 6 hours and then again at Day 1, 2, and 3 post first dose. During weeks 3-8, participants will be instructed to take valacyclovir and return to the clinic for one follow-up visit each week to provide plasma samples for HIV-1 detection.

Participants will be asked to return to the clinic for 3 follow-up visits after study drug discontinuation to provide plasma samples for HIV-1 detection.

Participants will be asked to complete a daily symptom and medication diary. All supplies and study medical will be provided.

This is an outpatient study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years old
  • HIV-1 seropositive
  • CD4 count>250 cell/mm3
  • Detectable HIV-1 plasma viral load
  • HSV-1 & 2 seronegative.
  • Not on HIV antiretroviral therapy or planning to initiate antiretroviral therapy during the study period.
  • Not intending to move out of the area for duration of study participation
  • Willing and able to provide independent written informed consent.
  • Willing and able to undergo clinical evaluations.
  • Willing and able to take study drug as directed.
  • Willing and able to adhere to follow-up schedule

Exclusion Criteria:

  • Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.
  • Use of ganciclovir, foscarnet, or cidofovir
  • History of evidence of CMV disease
  • Known medical history of seizures
  • Known renal insufficiency, defined as serum creatine >1.5 mg/dl
  • AST or ALT >3times upper limit of normal
  • Hematocrit <30%
  • Neutropenia, defined as absolute neutrophil count <1000
  • Thrombocytopenia, defined as platelet count <75,000
  • History of thrombotic microangiopathy
  • For women, pregnancy as confirmed by a urine pregnancy test
  • Any other condition which, in the opinion of the principal investigator, may compromise the ability to follow study procedures and complete the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059084

Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Anna Wald, MD, MPH University of Washington
  More Information

No publications provided

Responsible Party: Anna Wald, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01059084     History of Changes
Other Study ID Numbers: 37304-B
Study First Received: January 27, 2010
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
HIV
Valacyclovir
Valtrex®

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Acyclovir
Valacyclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014