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Valganciclovir Prevention of Cytomegalovirus (CMV) Organ Damage Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Valganciclovir Prevention of Cytomegalovirus (CMV) Organ Damage conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Valganciclovir Prevention of Cytomegalovirus (CMV) Organ Damage Clinical research trials and Valganciclovir Prevention of Cytomegalovirus (CMV) Organ Damage healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Valganciclovir Prevention of Cytomegalovirus (CMV) Organ Damage. Valganciclovir Prevention of Cytomegalovirus (CMV) Organ Damage Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Valganciclovir Prevention of Cytomegalovirus (CMV) Organ Damage clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Valganciclovir Prevention of Cytomegalovirus (CMV) Organ Damage condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Valganciclovir Prevention of Cytomegalovirus (CMV) Organ Damage  Valganciclovir Prevention of Cytomegalovirus (CMV) Organ Damage
Valganciclovir Prevention of Cytomegalovirus (CMV) Organ Damage
For Condition: Cytomegalovirus Infections,HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to find out whether treatment with valganciclovir is safe and effective in preventing CMV organ damage. Some patients with weakened immune systems have a high risk of developing CMV disease, an opportunistic (AIDS-related) infection. Doctors want to see if giving valganciclovir will help prevent the disease in patients who are at high risk for it, and if it is an effective treatment for CMV disease, especially CMV retinitis (eye disease). This study has been changed to include new information: Valganciclovir has been approved by the FDA for the treatment of CMV retinitis.
Details: Patients receiving highly active antiretroviral therapy (HAART), who, despite HAART, have an absolute CD4 count below 100/mm3, may be at risk of CMV EOD. This high risk justifies testing a strategy of screening patients for CMV viremia and pre-emptively treating those who are viremic, with potent anti-CMV therapy. Additionally, patients who develop CMV retinitis or other EOD will be followed for response to therapy. [AS PER AMENDMENT 01/16/02: Induction and maintenance treatment with oral valganciclovir is effective for the treatment of CMV retinitis. Valganciclovir has been approved by the FDA for the treatment of CMV retinitis. Currently, there are no data to support use of this drug for extraocular CMV disease.] Step 1: Patients have an ophthalmologic exam every 24 weeks and are screened every 8 weeks for CMV viremia. Patients positive for CMV DNA at entry to Step 1 or who develop a qualitatively positive result are randomized 1:1 to Step 2. If CMV EOD develops prior to randomization to Step 2, patients are encouraged to enter Step 3. Step 2: Patients receive either valganciclovir or placebo. Patients are monitored for development of CMV EOD with an ophthalmologic exam and an extra-ocular CMV symptoms questionnaire every 8 weeks. Blood samples for CMV viremia continue to be collected every 8 weeks. Patients who develop CMV EOD progress to Step 3. Step 3: Patients are followed every 12 weeks with an ophthalmologic exam, other clinical and laboratory evaluations, and a quality-of-life assessment. Valganciclovir therapy is offered to patients with CMV retinitis for 3 weeks or more if retinitis remains active. Antiviral resistance is assessed in all patients in Step 3. All patients in all steps are followed to a final closing date. After the study is closed, valganciclovir is provided for patients in Step 3 who are receiving valganciclovir for treatment of CMV retinitis, under the auspices of Roche, until it is approved for marketing. [AS PER AMENDMENT 01/16/02: "until it is approved for marketing" has been deleted and replaced by: Valganciclovir has been approved by the FDA for the treatment of CMV retinitis and is now commercially available. Roche will continue to provide this study medication to patients. In addition, patients should be advised to take valganciclovir after a meal.]
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Are 13 years or older (consent of parent or guardian required if under 18). - Have a viral load (level of HIV in the blood) of more than 400 copies/ml. - Have a CD4 cell count below 100 cells/mm3. - Have taken an anti-HIV drug combination for 3 months or longer, or are not taking an anti-HIV drug combination and do not plan to start one for at least 3 months after study entry. - Show evidence of CMV. Exclusion Criteria Patients will not be eligible for this study if they: - Have ever had CMV organ disease. - Are receiving certain antiviral drugs for CMV prevention. - Are pregnant or breast-feeding. - Have ongoing requirements for foscarnet and cidofovir. (This study has been changed to include this requirement.)
Total Enrollment: 750
Location and Contact Information:
Overall Study Official:
MarkJacobson, Study Chair,
Cornell Univ Med Ctr *Recruiting*
New York City, New York, 10021
United States
Recruiting Valery Hughes 212-746-4393
Univ of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Carol Greisberger 716-275-5871
Univ of Washington *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Jeanne Conley 206-731-8877
Univ of Colorado Health Sciences Ctr *Recruiting*
Denver, Colorado, 80262
United States
Recruiting M Ray 303-372-5535
Indiana Univ Hosp *Recruiting*
Indianapolis, Indiana, 462025250
United States
Recruiting Beth Zwickl 317-274-8456
Miriam Hosp / Brown Univ *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
San Francisco Gen Hosp *Recruiting*
San Francisco, California, 941102859
United States
Recruiting Marc Gould 415-476-9296
Georgetown Univ Med Ctr *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Scott Watson 202-687-7387
Univ of California, San Diego *Recruiting*
San Diego, California, 92103
United States
Recruiting Jill Kunkel 619-543-8080
University of Maryland, Institute of Human Virology *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Susan LaSalvia 410-706-2785
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium *No longer recruiting*
San Jose, California, 951282699
United States
No longer recruiting
Wishard Hosp *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Scott Hamilton 317-630-6023
Beth Israel Med Ctr *Recruiting*
New York City, New York, 10003
United States
Recruiting Ann Marshak 212-420-4432
Boston Medical Center (Harvard) *No longer recruiting*
Boston, Massachusetts, 02118
United States
No longer recruiting
Univ of Southern California / LA County USC Med Ctr *Recruiting*
Los Angeles, California, 900331079
United States
Recruiting Luis Mendez 323-343-8283
SUNY / Erie County Med Ctr at Buffalo *No longer recruiting*
Buffalo, New York, 14215
United States
No longer recruiting
St Mary's Hosp (Univ of Rochester/Infectious Diseases) *Recruiting*
Rochester, New York, 14642
United States
Recruiting Carol Greisberger 716-275-5871
Univ of Puerto Rico *Recruiting*
San Juan, , 009365067
Puerto Rico
Recruiting Virginia Ramirez 787-767-9192
Columbia Presbyterian Med Ctr *No longer recruiting*
New York City, New York, 10032
United States
No longer recruiting
Univ of Pennsylvania at Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Christopher Helker 215-349-8092
Ohio State Univ Hosp Clinic *Recruiting*
Columbus, Ohio, 432101228
United States
Recruiting Judith Neidig 614-293-8112
Univ of Minnesota *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Christine Fietzer 612-625-1462
Marin County Specialty Clinic *Recruiting*
San Rafael, California, 94903
United States
Recruiting Julieann Lewis 415-514-0550
Community Health Network Inc *Recruiting*
Rochester, New York, 14642
United States
Recruiting Carol Greisberger 716-275-5871
Univ of Texas Galveston *Recruiting*
Galveston, Texas, 775550435
United States
Recruiting Karen Waterman 409-772-0361
Bellevue Hosp / New York Univ Med Ctr *Recruiting*
New York City, New York, 10016
United States
Recruiting Maura Laverty 212-263-6565
Brigham and Womens Hosp *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Carolyn Koziol 617-732-5635
Univ of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Christine Tripoli 412-647-0771
Vanderbilt Univ Med Ctr *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Victoria Harris 615-467-0154
Case Western Reserve Univ *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Michael Chance 216-844-8051
Mount Sinai Med Ctr *No longer recruiting*
New York City, New York, 10029
United States
No longer recruiting
Brown Univ / The Miriam Hosp *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-331-8500
Northwestern Univ Med School *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Baiba Berzins 312-695-5012
Stanford Univ Med Ctr *Recruiting*
Stanford, California, 943055107
United States
Recruiting Debbie Slamowitz 650-723-2804
Univ of Hawaii *Recruiting*
Honolulu, Hawaii, 96816
United States
Recruiting Debra Ogata-Arakaki 808-737-2751
Methodist Hosp of Indiana / Life Care Clinic *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Sarah Ryan 317-929-2917
MetroHealth Med Ctr *No longer recruiting*
Cleveland, Ohio, 441091998
United States
No longer recruiting
UCLA CARE Ctr *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Susan McCarthy 310-206-8029
Boston Med Ctr (Pediatric) *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Anne Regan 617-414-5813
Cornell Clinical Trials Unit - Chelsea Clinic *Recruiting*
New York City, New York, 10011
United States
Recruiting Todd Stroberg 212-746-7198
Emory Univ *Recruiting*
Atlanta, Georgia, 30308
United States
Recruiting Beth Dean 404-616-0654
Nebraska Health System *Recruiting*
Omaha, Nebraska, 68198-5130
United States
Recruiting Frances Meter 402-559-8163
San Mateo AIDS Program / Stanford Univ *Recruiting*
Stanford, California, 943055107
United States
Recruiting Debbie Slamowitz 650-723-2804
Johns Hopkins Hosp *No longer recruiting*
Baltimore, Maryland, 21287
United States
No longer recruiting
Willow Clinic *Recruiting*
Menlo Park, California, 94025
United States
Recruiting Debbie Slamowitz 650-723-2804
Philadelphia Veterans Administration Med Ctr *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Joseph Quinn 215-349-8092
Harvard (Massachusetts Gen Hosp) *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Teri Flynn 617-726-3819
Univ of Cincinnati *Recruiting*
Cincinnati, Ohio, 452670405
United States
Recruiting Tammy Powell 513-584-8373
Presbyterian Med Ctr *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Maureen O'Connell 215-349-8092
Beth Israel Deaconess - West Campus *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Helen Fitch 617-632-0785
Univ of Alabama at Birmingham *No longer recruiting*
Birmingham, Alabama, 35294
United States
No longer recruiting
Univ of Iowa Hosp and Clinics *Recruiting*
Iowa City, Iowa, 52242-1201
United States
Recruiting Julie Katseres 319-353-8441
Univ of Miami School of Medicine *Recruiting*
Miami, Florida, 331361013
United States
Recruiting Leslie Thompson 305-243-3838
Cook County Hosp *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Joanne Despotes 312-572-4545
Univ of North Carolina *Recruiting*
Chapel Hill, North Carolina, 275997215
United States
Recruiting Barbara Longmire 919-966-7883
Univ of Texas, Southwestern Med Ctr of Dallas *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Charla Andrews 214-590-0414
Julio Arroyo *Recruiting*
West Columbia, South Carolina, 29169
United States
Recruiting Michael Klebert 314-454-0058
Rush Presbyterian - Saint Luke's Med Ctr *No longer recruiting*
Chicago, Illinois, 60612
United States
No longer recruiting
Additional Information:
Study ID Numbers: ACTG A5030; AACTG A5030
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006145
Other Cytomegalovirus Infections Studies:
1. The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients
2. A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus
3. Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
4. A Study of Lobucavir in Patients with AIDS
5. A Study of AZT Plus Ganciclovir in Patients with AIDS and Cytomegalovirus (CMV) Infection
Related Studies:
Other Cytomegalovirus Infections Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials
Valganciclovir Prevention of Cytomegalovirus (CMV) Organ Damage
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