A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons

Conditions

• Herpes Genitalis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• valacyclovir hydrochloride — DRUG
  valacyclovir hydrochloride

Study Details

This clinical research study will be an international trial evaluating the safety and effectiveness of a marketed drug compared to placebo (like a sugar pill) for the suppression of repeated genital herpes infections in HIV-infected subjects with CD4+ count \<100 cells/mm3.

Key Dates

Start date

Mar 12, 2004

Status verified

Nov 2020

Primary completion

Oct 15, 2004

Completion

Oct 15, 2004

Study Design

Enrollment

7 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Suppressive + Episodic Therapy
  Valaciclovir (VAL) 500mg twice daily for 6 months, and episodic treatment with VAL 1000mg twice daily for 5 days or 10 days, when required for treatment of a genital herpes recurrence.
• Placebo Comparator: Episodic Therapy
  Matching placebo twice daily for 6 months, and episodic treatment with VAL 1000mg twice daily for 5 or 10 days, when required for treatment of a genital herpes recurrence.

Primary Outcome Measure

Adverse Events [ Time Frame: Up to 6 months ]

Locations (3)

Find similar trials in Altamonte Springs, FL