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

Primary Purpose

Cytomegalovirus Infections, HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Valganciclovir
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cytomegalovirus Infections focused on measuring Ganciclovir, Cytomegalovirus, Cytomegalovirus Infections, Administration, Oral, Antiviral Agents, Polymerase Chain Reaction, Viremia, DNA, Viral

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alabama Therapeutics CRS
  • USC CRS
  • UCLA CARE Center CRS
  • Stanford CRS
  • Ucsd, Avrc Crs
  • Ucsf Aids Crs
  • Santa Clara Valley Med. Ctr.
  • San Mateo County AIDS Program
  • Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
  • University of Colorado Hospital CRS
  • Georgetown University CRS (GU CRS)
  • Univ. of Miami AIDS CRS
  • The Ponce de Leon Ctr. CRS
  • Univ. of Hawaii at Manoa, Leahi Hosp.
  • Northwestern University CRS
  • Cook County Hosp. CORE Ctr.
  • Rush Univ. Med. Ctr. ACTG CRS
  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
  • Indiana Univ. School of Medicine, Wishard Memorial
  • Methodist Hosp. of Indiana
  • Univ. of Iowa Healthcare, Div. of Infectious Diseases
  • IHV Baltimore Treatment CRS
  • Johns Hopkins Adult AIDS CRS
  • Massachusetts General Hospital ACTG CRS
  • Bmc Actg Crs
  • BMC, Div. of Ped Infectious Diseases
  • Beth Israel Deaconess Med. Ctr., ACTG CRS
  • Brigham and Women's Hosp. ACTG CRS
  • SSTAR, Family Healthcare Ctr.
  • University of Minnesota, ACTU
  • Washington U CRS
  • Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
  • SUNY - Buffalo, Erie County Medical Ctr.
  • Beth Israel Med. Ctr., ACTU
  • Cornell CRS
  • NY Univ. HIV/AIDS CRS
  • Weill Med. College of Cornell Univ., The Cornell CTU
  • Columbia Univ., HIV Prevention and Treatment Medical Ctr.
  • AIDS Care CRS
  • McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit
  • Univ. of Rochester ACTG CRS
  • Unc Aids Crs
  • Univ. of Cincinnati CRS
  • Case CRS
  • MetroHealth CRS
  • Cleveland Clinic Foundation, Div. of Medicine, Infectious Diseases
  • The Ohio State University Medical Center
  • Hosp. of the Univ. of Pennsylvania CRS
  • Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
  • Pitt CRS
  • Rhode Island Hosp.
  • The Miriam Hosp. ACTG CRS
  • Vanderbilt Therapeutics CRS
  • Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
  • Univ. of Texas Medical Branch, ACTU
  • University of Washington AIDS CRS
  • Puerto Rico-AIDS CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 7, 2000
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00006145
Brief Title
Preventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections, HIV Infections
Keywords
Ganciclovir, Cytomegalovirus, Cytomegalovirus Infections, Administration, Oral, Antiviral Agents, Polymerase Chain Reaction, Viremia, DNA, Viral

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Masking
Double
Enrollment
350 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Valganciclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Jacobson, MD
Organizational Affiliation
University of California, San Francisco and San Francisco General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David A. Wohl, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Therapeutics CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
USC CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA CARE Center CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford CRS
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Ucsd, Avrc Crs
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Ucsf Aids Crs
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Santa Clara Valley Med. Ctr.
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
San Mateo County AIDS Program
City
San Mateo
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
University of Colorado Hospital CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Georgetown University CRS (GU CRS)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Univ. of Miami AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
The Ponce de Leon Ctr. CRS
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Univ. of Hawaii at Manoa, Leahi Hosp.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Cook County Hosp. CORE Ctr.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Rush Univ. Med. Ctr. ACTG CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana Univ. School of Medicine, Wishard Memorial
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Methodist Hosp. of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Univ. of Iowa Healthcare, Div. of Infectious Diseases
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
IHV Baltimore Treatment CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Adult AIDS CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Bmc Actg Crs
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
BMC, Div. of Ped Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Med. Ctr., ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Brigham and Women's Hosp. ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
SSTAR, Family Healthcare Ctr.
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
University of Minnesota, ACTU
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
SUNY - Buffalo, Erie County Medical Ctr.
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Beth Israel Med. Ctr., ACTU
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Cornell CRS
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
NY Univ. HIV/AIDS CRS
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Med. College of Cornell Univ., The Cornell CTU
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia Univ., HIV Prevention and Treatment Medical Ctr.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
AIDS Care CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14607
Country
United States
Facility Name
McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Univ. of Rochester ACTG CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Unc Aids Crs
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Univ. of Cincinnati CRS
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case CRS
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth CRS
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic Foundation, Div. of Medicine, Infectious Diseases
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hosp. of the Univ. of Pennsylvania CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pitt CRS
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hosp.
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
The Miriam Hosp. ACTG CRS
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Vanderbilt Therapeutics CRS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Univ. of Texas Medical Branch, ACTU
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
University of Washington AIDS CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Puerto Rico-AIDS CRS
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
12022911
Citation
Cocohoba JM, McNicholl IR. Valganciclovir: an advance in cytomegalovirus therapeutics. Ann Pharmacother. 2002 Jun;36(6):1075-9. doi: 10.1345/aph.1A393.
Results Reference
background
PubMed Identifier
15125867
Citation
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.
Results Reference
background
PubMed Identifier
12905142
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. doi: 10.1086/375843. Epub 2003 Jul 29.
Results Reference
background
PubMed Identifier
11772283
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. doi: 10.1517/13543784.10.9.1745.
Results Reference
background
PubMed Identifier
19632953
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 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.
Results Reference
result

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

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