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

NCT00006145 | Completed Phase 3

• 4 other identifiers: A503010170ACTG A5030AACTG A5030
• Study Type: interventional
• Target: 350
• Locations: 2 countries
• Sites: 57

Brief 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.

Conditions

Cytomegalovirus Infections; HIV Infections

Keywords

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

Interventions

Valganciclovir DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (57)

Alabama Therapeutics CRS

Birmingham, Alabama, 35294, United States

Location

USC CRS

Los Angeles, California, 90033, United States

Location

UCLA CARE Center CRS

Los Angeles, California, 90095, United States

Location

Stanford CRS

Palo Alto, California, 94305, United States

Location

Ucsd, Avrc Crs

San Diego, California, 92103, United States

Location

Ucsf Aids Crs

San Francisco, California, 94110, United States

Location

Santa Clara Valley Med. Ctr.

San Jose, California, 95128, United States

Location

San Mateo County AIDS Program

San Mateo, California, 94305, United States

Location

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

San Rafael, California, 94903, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80262, United States

Location

Georgetown University CRS (GU CRS)

Washington D.C., District of Columbia, 20007, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, 33136, United States

Location

The Ponce de Leon Ctr. CRS

Atlanta, Georgia, 30308, United States

Location

Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, 96816, United States

Location

Northwestern University CRS

Chicago, Illinois, 60611, United States

Location

Cook County Hosp. CORE Ctr.

Chicago, Illinois, 60612, United States

Location

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, 60612, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 46202, United States

Location

Indiana Univ. School of Medicine, Wishard Memorial

Indianapolis, Indiana, 46202, United States

Location

Methodist Hosp. of Indiana

Indianapolis, Indiana, 46202, United States

Location

Univ. of Iowa Healthcare, Div. of Infectious Diseases

Iowa City, Iowa, 52242, United States

Location

IHV Baltimore Treatment CRS

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, 02114, United States

Location

Bmc Actg Crs

Boston, Massachusetts, 02118, United States

Location

BMC, Div. of Ped Infectious Diseases

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, 02215, United States

Location

Brigham and Women's Hosp. ACTG CRS

Boston, Massachusetts, 02215, United States

Location

SSTAR, Family Healthcare Ctr.

Fall River, Massachusetts, 02720, United States

Location

University of Minnesota, ACTU

Minneapolis, Minnesota, 55455, United States

Location

Washington U CRS

St Louis, Missouri, 63110, United States

Location

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

Omaha, Nebraska, 68198, United States

Location

SUNY - Buffalo, Erie County Medical Ctr.

Buffalo, New York, 14215, United States

Location

Beth Israel Med. Ctr., ACTU

New York, New York, 10003, United States

Location

Cornell CRS

New York, New York, 10011, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Weill Med. College of Cornell Univ., The Cornell CTU

New York, New York, 10021, United States

Location

Columbia Univ., HIV Prevention and Treatment Medical Ctr.

New York, New York, 10032, United States

Location

AIDS Care CRS

Rochester, New York, 14607, United States

Location

McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit

Rochester, New York, 14642, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 27599, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 45267, United States

Location

Case CRS

Cleveland, Ohio, 44106, United States

Location

MetroHealth CRS

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic Foundation, Div. of Medicine, Infectious Diseases

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.

Philadelphia, Pennsylvania, 19104, United States

Location

Pitt CRS

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hosp.

Providence, Rhode Island, 02906, United States

Location

The Miriam Hosp. ACTG CRS

Providence, Rhode Island, 02906, United States

Location

Vanderbilt Therapeutics CRS

Nashville, Tennessee, 37203, United States

Location

Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic

Dallas, Texas, 75235, United States

Location

Univ. of Texas Medical Branch, ACTU

Galveston, Texas, 77555, United States

Location

University of Washington AIDS CRS

Seattle, Washington, 98104, United States

Location

Puerto Rico-AIDS CRS

San Juan, 00935, Puerto Rico

Location

Related Publications (5)

• Cocohoba JM, McNicholl IR. Valganciclovir: an advance in cytomegalovirus therapeutics. Ann Pharmacother. 2002 Jun;36(6):1075-9. doi: 10.1345/aph.1A393.

  PMID: 12022911 BACKGROUND

• De Clercq E. Antiviral drugs in current clinical use. J Clin Virol. 2004 Jun;30(2):115-33. doi: 10.1016/j.jcv.2004.02.009.

  PMID: 15125867 BACKGROUND

• 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. doi: 10.1086/375843. Epub 2003 Jul 29.

  PMID: 12905142 BACKGROUND

• 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. doi: 10.1517/13543784.10.9.1745.

  PMID: 11772283 BACKGROUND

• 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 despite low CD4+ cell counts and CMV viremia: results of ACTG protocol A5030. HIV Clin Trials. 2009 May-Jun;10(3):143-52. doi: 10.1310/hct1003-143.

  PMID: 19632953 RESULT

MeSH Terms

Conditions

Cytomegalovirus Infections; HIV Infections; Multiple Acyl Coenzyme A Dehydrogenase Deficiency; Viremia

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Mitochondrial Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mark Jacobson, MD

  University of California, San Francisco and San Francisco General Hospital

  STUDY CHAIR

• David A. Wohl, MD

  University of North Carolina, Chapel Hill

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2000
• First Posted: August 31, 2001
• Study Start: August 1, 2000
• Study Completion: February 1, 2006
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (56); PR (1)