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.

Condition	Treatment or Intervention	Phase
Cytomegalovirus Infections HIV Infections	Drug: Valganciclovir	Phase III

Further Study Details: 

Expected Total Enrollment:  350

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States
California
      San Francisco Gen Hosp, San Francisco,  California,  941102859,  United States
      Stanford Univ Med Ctr, Stanford,  California,  943055107,  United States
      UCLA CARE Ctr, Los Angeles,  California,  90095,  United States
      Univ of Southern California / LA County USC Med Ctr, Los Angeles,  California,  900331079,  United States
      San Mateo AIDS Program / Stanford Univ, Stanford,  California,  943055107,  United States
      Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium, San Jose,  California,  951282699,  United States
      Marin County Specialty Clinic, San Rafael,  California,  94903,  United States
      Willow Clinic, Menlo Park,  California,  94025,  United States
      Univ of California, San Diego, San Diego,  California,  92103,  United States
Colorado
      Univ of Colorado Health Sciences Ctr, Denver,  Colorado,  80262,  United States
District of Columbia
      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States
Florida
      Univ of Miami School of Medicine, Miami,  Florida,  331361013,  United States
Georgia
      Emory Univ, Atlanta,  Georgia,  30308,  United States
Hawaii
      Univ of Hawaii, Honolulu,  Hawaii,  96816,  United States
Illinois
      Northwestern Univ Med School, Chicago,  Illinois,  60611,  United States
      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States
      Cook County Hosp, Chicago,  Illinois,  60612,  United States
Indiana
      Indiana Univ Hosp, Indianapolis,  Indiana,  462025250,  United States
      Methodist Hosp of Indiana / Life Care Clinic, Indianapolis,  Indiana,  46202,  United States
      Wishard Hosp, Indianapolis,  Indiana,  46202,  United States
Iowa
      Univ of Iowa Hosp and Clinics, Iowa City,  Iowa,  52242-1201,  United States
Maryland
      Johns Hopkins Hosp, Baltimore,  Maryland,  21287,  United States
      University of Maryland, Institute of Human Virology, Baltimore,  Maryland,  21201,  United States
Massachusetts
      Harvard (Massachusetts Gen Hosp), Boston,  Massachusetts,  02114,  United States
      Beth Israel Deaconess - West Campus, Boston,  Massachusetts,  02215,  United States
      Brigham and Womens Hosp, Boston,  Massachusetts,  02215,  United States
      Boston Medical Center (Harvard), Boston,  Massachusetts,  02118,  United States
      Boston Med Ctr (Pediatric), Boston,  Massachusetts,  02118,  United States
Minnesota
      Univ of Minnesota, Minneapolis,  Minnesota,  55455,  United States
Nebraska
      Nebraska Health System, Omaha,  Nebraska,  68198-5130,  United States
New York
      Univ of Rochester Medical Center, Rochester,  New York,  14642,  United States
      Bellevue Hosp / New York Univ Med Ctr, New York,  New York,  10016,  United States
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States
      Cornell Univ Med Ctr, New York,  New York,  10021,  United States
      SUNY / Erie County Med Ctr at Buffalo, Buffalo,  New York,  14215,  United States
      Beth Israel Med Ctr, New York,  New York,  10003,  United States
      Columbia Presbyterian Med Ctr, New York,  New York,  10032,  United States
      St Mary's Hosp (Univ of Rochester/Infectious Diseases), Rochester,  New York,  14642,  United States
      Cornell Clinical Trials Unit - Chelsea Clinic, New York,  New York,  10011,  United States
      Community Health Network Inc, Rochester,  New York,  14642,  United States
North Carolina
      Univ of North Carolina, Chapel Hill,  North Carolina,  275997215,  United States
Ohio
      Case Western Reserve Univ, Cleveland,  Ohio,  44106,  United States
      Univ of Cincinnati, Cincinnati,  Ohio,  452670405,  United States
      Ohio State Univ Hosp Clinic, Columbus,  Ohio,  432101228,  United States
      MetroHealth Med Ctr, Cleveland,  Ohio,  441091998,  United States
Pennsylvania
      Univ of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States
      Univ of Pennsylvania at Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States
      Philadelphia Veterans Administration Med Ctr, Philadelphia,  Pennsylvania,  19104,  United States
      Presbyterian Med Ctr, Philadelphia,  Pennsylvania,  19104,  United States
Rhode Island
      Brown Univ / The Miriam Hosp, Providence,  Rhode Island,  02906,  United States
      Miriam Hosp / Brown Univ, Providence,  Rhode Island,  02906,  United States
South Carolina
      Julio Arroyo, West Columbia,  South Carolina,  29169,  United States
Tennessee
      Vanderbilt Univ Med Ctr, Nashville,  Tennessee,  37203,  United States
Texas
      Univ of Texas Galveston, Galveston,  Texas,  775550435,  United States
      Univ of Texas, Southwestern Med Ctr of Dallas, Dallas,  Texas,  75390,  United States
Washington
      Univ of Washington, Seattle,  Washington,  98104,  United States
Puerto Rico
      Univ of Puerto Rico, San Juan,  009365067,  Puerto Rico

Study chairs or principal investigators

Mark Jacobson, MD,  Study Chair,  University of California, San Francisco and San Francisco General Hospital   
David A. Wohl, MD,  Study Chair,  University of North Carolina   

Study ID Numbers:  ACTG A5030; AACTG A5030
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  August 7, 2000
ClinicalTrials.gov Identifier:  NCT00006145
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08