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NCT00006145 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
A Phase III, Prospective, Randomized, Double-Blind Trial of Valganciclovir Pre-Emptive Therapy for Cytomegalovirus (CMV) Viremia as Detected by Plasma CMV DNA PCR Assay

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00006145
Other study ID # A5030
Secondary ID 10170ACTG A5030A
Status Completed
Phase Phase 3
First received
Last updated
Start date August 2000
Est. completion date February 2006

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility Note: Per a recommendation from NIAID Therapeutic Trials Data Safety Monitoring Board (DSMB), this trial will close on 10/03/05. The DSMB has determined that the study will reach the primary objective. All participants not on valganciclovir must complete all study evaluations by 08/31/05; all participants taking valganciclovir must complete study evaluations by 10/03/05. Inclusion Criteria for Step 1: - 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 for Step 1: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Valganciclovir

Locations
Country Name City State
Puerto Rico Puerto Rico-AIDS CRS San Juan
United States The Ponce de Leon Ctr. CRS Atlanta Georgia
United States University of Colorado Hospital CRS Aurora Colorado
United States IHV Baltimore Treatment CRS Baltimore Maryland
United States Johns Hopkins Adult AIDS CRS Baltimore Maryland
United States Alabama Therapeutics CRS Birmingham Alabama
United States Beth Israel Deaconess Med. Ctr., ACTG CRS Boston Massachusetts
United States Bmc Actg Crs Boston Massachusetts
United States BMC, Div. of Ped Infectious Diseases Boston Massachusetts
United States Brigham and Women's Hosp. ACTG CRS Boston Massachusetts
United States Massachusetts General Hospital ACTG CRS Boston Massachusetts
United States SUNY - Buffalo, Erie County Medical Ctr. Buffalo New York
United States Unc Aids Crs Chapel Hill North Carolina
United States Cook County Hosp. CORE Ctr. Chicago Illinois
United States Northwestern University CRS Chicago Illinois
United States Rush Univ. Med. Ctr. ACTG CRS Chicago Illinois
United States Univ. of Cincinnati CRS Cincinnati Ohio
United States Case CRS Cleveland Ohio
United States Cleveland Clinic Foundation, Div. of Medicine, Infectious Diseases Cleveland Ohio
United States MetroHealth CRS Cleveland Ohio
United States The Ohio State University Medical Center Columbus Ohio
United States Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic Dallas Texas
United States SSTAR, Family Healthcare Ctr. Fall River Massachusetts
United States Univ. of Texas Medical Branch, ACTU Galveston Texas
United States Univ. of Hawaii at Manoa, Leahi Hosp. Honolulu Hawaii
United States Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis Indiana
United States Indiana Univ. School of Medicine, Wishard Memorial Indianapolis Indiana
United States Methodist Hosp. of Indiana Indianapolis Indiana
United States Univ. of Iowa Healthcare, Div. of Infectious Diseases Iowa City Iowa
United States UCLA CARE Center CRS Los Angeles California
United States USC CRS Los Angeles California
United States Univ. of Miami AIDS CRS Miami Florida
United States University of Minnesota, ACTU Minneapolis Minnesota
United States Vanderbilt Therapeutics CRS Nashville Tennessee
United States Beth Israel Med. Ctr., ACTU New York New York
United States Columbia Univ., HIV Prevention and Treatment Medical Ctr. New York New York
United States Cornell CRS New York New York
United States NY Univ. HIV/AIDS CRS New York New York
United States Weill Med. College of Cornell Univ., The Cornell CTU New York New York
United States Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. Omaha Nebraska
United States Stanford CRS Palo Alto California
United States Hosp. of the Univ. of Pennsylvania CRS Philadelphia Pennsylvania
United States Univ. of Pennsylvania Health System, Presbyterian Med. Ctr. Philadelphia Pennsylvania
United States Pitt CRS Pittsburgh Pennsylvania
United States Rhode Island Hosp. Providence Rhode Island
United States The Miriam Hosp. ACTG CRS Providence Rhode Island
United States AIDS Care CRS Rochester New York
United States McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit Rochester New York
United States Univ. of Rochester ACTG CRS Rochester New York
United States Washington U CRS Saint Louis Missouri
United States Ucsd, Avrc Crs San Diego California
United States Ucsf Aids Crs San Francisco California
United States Santa Clara Valley Med. Ctr. San Jose California
United States San Mateo County AIDS Program San Mateo California
United States Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic San Rafael California
United States University of Washington AIDS CRS Seattle Washington
United States Georgetown University CRS (GU CRS) Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (5)

Cocohoba JM, McNicholl IR. Valganciclovir: an advance in cytomegalovirus therapeutics. Ann Pharmacother. 2002 Jun;36(6):1075-9. Review. — View Citation

De Clercq E. Antiviral drugs in current clinical use. J Clin Virol. 2004 Jun;30(2):115-33. Review. — View Citation

Erice A, Tierney C, Hirsch M, Caliendo AM, Weinberg A, Kendall MA, Polsky B; AIDS Clinical Trials Group Protocol 360 Study Team. Cytomegalovirus (CMV) and human immunodeficiency virus (HIV) burden, CMV end-organ disease, and survival in subjects with advanced HIV infection (AIDS Clinical Trials Group Protocol 360). Clin Infect Dis. 2003 Aug 15;37(4):567-78. Epub 2003 Jul 29. — View Citation

Reusser P. Oral valganciclovir: a new option for treatment of cytomegalovirus infection and disease in immunocompromised hosts. Expert Opin Investig Drugs. 2001 Sep;10(9):1745-53. Review. — View Citation

Wohl DA, Kendall MA, Andersen J, Crumpacker C, Spector SA, Feinberg J, Alston-Smith B, Owens S, Chafey S, Marco M, Maxwell S, Lurain N, Jabs D, Benson C, Keiser P, Jacobson MA; A5030 Study Team. Low rate of CMV end-organ disease in HIV-infected patients d — View Citation

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