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NCT00006145

Preventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2006-02-28

Brief Summary

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Cytomegalovirus (CMV) infection is a common opportunistic infection (OI) in HIV patients. The purpose of this study is to find out whether valganciclovir, an antiviral approved by the FDA for the treatment of CMV in the eye, is safe and effective in preventing CMV organ damage in people with HIV.

Detailed Description

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CMV infection, most commonly of the retina (also known as CMV retinitis), is a common OI observed in HIV patients. Despite treatment, CMV retinitis can result in severe visual impairment and CMV disease is associated with reduced survival time. HIV patients receiving highly active antiretroviral therapy (HAART) for HIV infection who have CD4 counts less than 100 cells/mm3 may be at increased risk of CMV infection and its complications. Valganciclovir was approved by the FDA on March 29, 2001 for treatment of the symptoms of CMV retinitis in patients with weakened immune systems, including people with HIV and AIDS. This study will evaluate the safety and efficacy of valganciclovir in preventing CMV organ damage in HIV patients.

This study will last approximately 6 years. Step 1 is the longitudinal screening phase of the study. Patients at high risk for CMV disease who are enrolled in the study will be screened every 8 weeks for CMV in the blood; medical history assessment, physical examination, and blood work will occur at each visit. Additional blood collection to monitor HIV infection will occur every 16 weeks. Patients will undergo opthalmologic examination every 24 weeks. Patients who develop detectable CMV in their blood during Step 1 then enter Step 2 of the study.

In version 3.0 of this study, participants who test positive for CMV viremia or who are currently in Step 2 will be automatically enrolled into Step 4 and will be randomly assigned to one of two groups: 1) 900 mg valganciclovir twice daily for 3 weeks, followed by 900 mg valganciclovir daily, or 2) placebo. Participants will enter Step 3 if and when they develop CMV end-organ disease, at which point all participants will be offered 900 mg valganciclovir twice daily for 3 weeks, then 900 valganciclovir daily thereafter.

Conditions

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Cytomegalovirus Infections HIV Infections

Keywords

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Ganciclovir Cytomegalovirus Cytomegalovirus Infections Administration, Oral Antiviral Agents Polymerase Chain Reaction Viremia DNA, Viral

Study Design

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Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Valganciclovir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV infected
* Viral load greater than 400 copies/ml
* CD4 count less than 100 cells/mm3
* Have taken HAART for 3 months or longer OR are not taking HAART and do not plan to start HAART for at least 3 months after study entry
* Have serum CMV IgG antibodies
* Have consent of parent or guardian if under 18 years of age
* Willing to use acceptable forms of contraception

Exclusion Criteria

* History of CMV end-organ disease
* Certain antiviral drugs for CMV prophylaxis within 8 weeks of study entry
* Pregnant or breastfeeding
* Currently require ongoing foscarnet or cidofovir. Limited courses of foscarnet or cidofovir for the treatment of diseases other than CMV are permitted if approved by the protocol chairs.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Jacobson, MD

Role: STUDY_CHAIR

University of California, San Francisco and San Francisco General Hospital

David A. Wohl, MD

Role: STUDY_CHAIR

University of North Carolina, Chapel Hill

Locations

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Alabama Therapeutics CRS

Birmingham, Alabama, United States

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USC CRS

Los Angeles, California, United States

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UCLA CARE Center CRS

Los Angeles, California, United States

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Stanford CRS

Palo Alto, California, United States

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Ucsd, Avrc Crs

San Diego, California, United States

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Ucsf Aids Crs

San Francisco, California, United States

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Santa Clara Valley Med. Ctr.

San Jose, California, United States

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San Mateo County AIDS Program

San Mateo, California, United States

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Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic

San Rafael, California, United States

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University of Colorado Hospital CRS

Aurora, Colorado, United States

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Georgetown University CRS (GU CRS)

Washington D.C., District of Columbia, United States

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Univ. of Miami AIDS CRS

Miami, Florida, United States

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The Ponce de Leon Ctr. CRS

Atlanta, Georgia, United States

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Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, United States

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Northwestern University CRS

Chicago, Illinois, United States

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Cook County Hosp. CORE Ctr.

Chicago, Illinois, United States

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Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, United States

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Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, United States

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Indiana Univ. School of Medicine, Wishard Memorial

Indianapolis, Indiana, United States

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Methodist Hosp. of Indiana

Indianapolis, Indiana, United States

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Univ. of Iowa Healthcare, Div. of Infectious Diseases

Iowa City, Iowa, United States

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IHV Baltimore Treatment CRS

Baltimore, Maryland, United States

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Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, United States

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Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, United States

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Bmc Actg Crs

Boston, Massachusetts, United States

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BMC, Div. of Ped Infectious Diseases

Boston, Massachusetts, United States

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Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, United States

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Brigham and Women's Hosp. ACTG CRS

Boston, Massachusetts, United States

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SSTAR, Family Healthcare Ctr.

Fall River, Massachusetts, United States

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University of Minnesota, ACTU

Minneapolis, Minnesota, United States

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Washington U CRS

St Louis, Missouri, United States

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Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.

Omaha, Nebraska, United States

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