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

NCT ID: NCT01059084

Last Updated: 2012-12-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-12-31

Brief Summary

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.

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.

Conditions

HIV; HIV Infections

Keywords

HIV; Valacyclovir; Valtrex®

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

Valacyclovir

1000 mg tid

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Anna Wald

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Wald, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Countries

United States

Other Identifiers

37304-B

Identifier Type: -

Identifier Source: org_study_id