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

NCT01059084 | Withdrawn DMC

• 1 other identifier: 37304-B
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV; HIV Infections

Keywords

HIV; Valacyclovir; Valtrex®

Outcome Measures

Primary Outcomes (1)

• To evaluate plasma HIV-1 levels after treatment with valacyclovir compared to baseline HIV-1 levels before treatment.

  Weeks (1-10)

Secondary Outcomes (1)

• To determine frequency of reverse transcriptase drug resistant mutations in HIV-1 after exposure to valacyclovir

  Weeks 7 and 8

Interventions

Valacyclovir DRUG

1000 mg tid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

MeSH Terms

Conditions

HIV Infections

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anna Wald, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: January 29, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 5, 2012

Record last verified: 2012-12