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Home > "A" Clinical Trials Conditions > A Study of Lobucavir in Patients with AIDS  A Study of Lobucavir in Patients with AIDS
A Study of Lobucavir in Patients with AIDS
For Condition: Cytomegalovirus Infections,HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: The purpose of this study is to see if lobucavir is a safe and effective treatment for cytomegalovirus in patients with AIDS.
Details: Patients receive 1 of 2 doses of lobucavir for 28 days, with 2 weeks of follow-up. Weekly clinic visits are required.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Aerosolized pentamidine. - TMP / SMX. - Isoniazid. - Dapsone. - Fluconazole. - Ketoconazole. - Rifabutin. - Fluoxetine HCl. - Acetaminophen. - Antacids. - Metamucil. - Multivitamins. - Other drugs with approval from sponsor. Patients must have: - AIDS. - CD4 count < 200 cells/mm3. - Cytomegalovirus ( CMV ) viruria and virosemenia. - No evidence of intraocular CMV. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Acute or chronic cardiovascular, pulmonary, renal, hepatic, pancreatic, hematologic, endocrine, neurological, or other unstable illness. - Inability to take oral medication. - Allergy to nucleoside analogs. - Diarrheal illness. - Poor venous access. - Positive test for drugs of abuse. - Any other condition that would render patient unsuitable for study. Patients with the following prior conditions are excluded: - History of pancreatitis. - Recent diarrheal illness. - History of weight loss. - Acute serious illness within 4 weeks prior to study entry. Prior Medication: Excluded within 4 weeks prior to study entry: - Erythropoietin. - Any agent with anti-CMV activity. - Other investigational agents. Prior Treatment: Excluded within 4 weeks prior to study entry: - Surgery. - Blood transfusion. Drug abuse.
Total Enrollment: 30
Location and Contact Information:
Mount Zion Med Ctr / UCSF
San Francisco, California, 94115
United States
San Francisco Veterans Adm Med Cntr
San Francisco, California, 94121
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Additional Information:
Study ID Numbers: 248A; AI459-007
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002352
Other Cytomegalovirus Infections Studies:
1. 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
2. A Study of Cidofovir in HIV-Infected Children with Cytomegalovirus (CMV) Disease
3. Transfusion Infections Pediatric Prospective Study (TRIPPS)
4. A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
5. A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
Related Studies:
Other Cytomegalovirus Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
A Study of Lobucavir in Patients with AIDS
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