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A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients Clinical research trials and A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients. A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients  A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
For Condition: Cytomegalovirus Infections,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Glaxo Wellcome
Synopsis: PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with CD4+ lymphocytes < 100 cells/mm3. To assess the impact of BW 256U87, high-dose oral acyclovir and low-dose oral acyclovir on survival. SECONDARY: To evaluate the effect of BW 256U87 on quality of life, the safety of the drug administered concurrently with standard antiretroviral agents and other essential therapies for the treatment and prevention of opportunistic diseases, and the efficacy of BW 256U87 in suppressing activation of other herpesviruses. To evaluate serologic and virologic risk factors for the development of CMV disease, including assessment of HIV activation, and the risk of developing drug-resistant CMV, HSV, and VZV. Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in patients with advanced HIV disease, although there is evidence that high doses of the drug may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after oral administration, has a higher absorption rate and may therefore provide inhibitory activity against CMV.
Details: Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in patients with advanced HIV disease, although there is evidence that high doses of the drug may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after oral administration, has a higher absorption rate and may therefore provide inhibitory activity against CMV. Patients are randomized to receive BW 256U87 alone or acyclovir alone as control at either high-dose or low-dose. The acyclovir controls will provide suppressive therapy for herpes simplex infections and may affect survival.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Recommended: - PCP prophylaxis. Allowed: - Any antiretroviral therapies available by prescription or through expanded access or Treatment IND programs, including combination or sequential use. - Chemotherapy for Kaposi's sarcoma, lymphoma, or other malignancies IF patient is hematologically stable for at least 30 days prior to study entry. - Discrete courses of oral or parenteral acyclovir for VZV or HSV infection, not to exceed 21 days per episode (may co-enroll on ACTG 169). For recurrent episodes, open-label acyclovir for a total of 60 days over a 12-month period is allowed. Study drug is interrupted. - Supportive therapies available by prescription, expanded access, or Treatment IND programs, such as G-CSF, GM-CSF, and erythropoietin. - Other medications necessary for the patient's welfare, at the discretion of the investigator. Patients must have: - HIV infection or AIDS-defining conditions. - CD4+ count < 100 cells/mm3. - IgG antibodies to CMV. - No active CMV disease or history of CMV end-organ disease. - Consent of parent or guardian if less than 18 years of age. - Ability to comply with protocol. NOTE: - Patients may be co-enrolled in ACTG primary infection Phase II/III studies, ACTG opportunistic infection protocols, or treatment protocols or similar studies sponsored by other research networks as long as those studies do not violate the restrictions placed on concomitant therapies and toxicity management. Prior Medication: Allowed: - PCP prophylaxis. - Any antiretroviral therapies available by prescription or through expanded access or Treatment IND programs, including combination or sequential use. - Chemotherapy for Kaposi's sarcoma, lymphoma, or other malignancies. - Acyclovir. - Supportive therapies available by prescription, expanded access, or Treatment IND programs, such as G-CSF, GM-CSF, and erythropoietin. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Nausea or vomiting that precludes oral dosing. - Ocular media opacities that preclude adequate visualization of fundi. - Pregnancy. - Known hypersensitivity to acyclovir. - Known lactose intolerance. Concurrent Medication: Excluded: - Systemic interferons and immunomodulators (including CMV hyperimmune serum/globulin and chronic corticosteroids at doses in excess of physiologic replacement). - Probenecid. - Investigational or marketed agents with potential activity against CMV, herpes simplex, and/or Varicella zoster, EXCEPT as specifically allowed. Patients with the following prior condition are excluded: - Pre-existing necrotizing retinopathy that may interfere with a subsequent diagnosis of CMV retinitis. Prior Medication: Excluded: - Prior ganciclovir, foscarnet, or any investigational anti-CMV agent including use of foscarnet for acyclovir-resistant herpes. - Interferons, immunomodulators (other than colony stimulating factors), or CMV hyperimmune globulin within 30 days prior to study entry.
Total Enrollment: 1200
Location and Contact Information:
Overall Study Official:
FeinbergJ, Study Chair,
Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Montreal Gen Hosp
Montreal, Quebec,
Canada
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
South Hosp
Stockholm, ,
Sweden
Saint Vincent's Hosp Med Centre
Sydney, ,
Australia
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Universitatsklinikum Rudolf Virchow
Berlin, ,
Germany
Johns Hopkins Hosp
Baltimore, Maryland, 212052196
United States
Royal Free Hosp
London, ,
United Kingdom
Universita Cattolica del Sacro Cuore
Rome, ,
Italy
CARE Ctr / UCLA Med Ctr
Los Angeles, California, 900951793
United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018
United States
Westminster Hosp
London, ,
United Kingdom
Univ TX Galveston Med Branch
Galveston, Texas, 775550882
United States
Toronto Hosp
Toronto, Ontario,
Canada
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Yale Univ
New Haven, Connecticut, 06519
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Medizinische Universibatspoliklinik Infekbiologie
BERN, ,
Switzerland
Montreal Chest Institute
Montreal, Quebec,
Canada
Univ of Washington / Madison Clinic
Seattle, Washington, 98122
United States
Girard Med Ctr
Philadelphia, Pennsylvania, 191046073
United States
Washington Univ
St. Louis, Missouri, 63110
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Southern Alberta HIV Clinic / Foothills Hosp
Calgary, Alberta,
Canada
Birmingham Veterans Administration Med Ctr
Birmingham, Alabama, 35233
United States
Sunnybrook Health Science Ctr
Toronto, Ontario,
Canada
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Services des Maladies Infectieuses
Paris Cedex 12, ,
France
Hvidovre Univ Hosp
Hvidore, ,
Denmark
Additional Information:
Study ID Numbers: ACTG 204; FDA 104C
Study Start Date:
Record last reviewed: June 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001038
Other Cytomegalovirus Infections Studies:
1. Phase III Randomized, Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection
2. Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2)
3. Immune Response to Cytomegalovirus
4. Potential Role of CMV in Restenosis Following Angioplasty, in Atherosclerosis, and in Endothelial Dysfunction
5. Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
Related Studies:
Other Cytomegalovirus Infections Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
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