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Home > "A" Clinical Trials Conditions > A Study of Dideoxycytidine in HIV-Infected Patients  A Study of Dideoxycytidine in HIV-Infected Patients
A Study of Dideoxycytidine in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine how much of a dose is absorbed by the body when zalcitabine ( dideoxycytidine; ddC ) is given orally and how long the drug stays in the body after absorption or intravenous (IV) administration. Laboratory tests have shown that ddC is effective in stopping the growth of the HIV in test tubes. The study will reveal the pharmacokinetic (blood levels) properties of this new drug and how long the drug remains in the body at each of six doses. This should be useful background information and should allow a simple and efficient comparative study of any new oral formulation, such as a tablet or capsule, since dose-related problems will already be known.
Details: Laboratory tests have shown that ddC is effective in stopping the growth of the HIV in test tubes. The study will reveal the pharmacokinetic (blood levels) properties of this new drug and how long the drug remains in the body at each of six doses. This should be useful background information and should allow a simple and efficient comparative study of any new oral formulation, such as a tablet or capsule, since dose-related problems will already be known. Patients are hospitalized and receive ddC twice, once by mouth and once by IV injection. Each patient receives the drug at one of six increasing doses, and no patient is studied at more than one dose level. Following each dose, toxicity is measured before the next higher dose is given. Several blood samples and urine specimens are taken to permit measurement of the amount of drug in the bloodstream and of the speed with which it is eliminated from the body.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Prior Medication: Allowed: - Oral nonabsorbable antifungal agents. Exclusion Criteria - Active drug or alcohol abuse. Co-existing Condition: - Patients with fever > 102 degrees F at study entry will be excluded. - Patients with fever > 102 degrees F at study entry will be excluded. Prior Medication: Excluded: - Chronic systemic medications. - Any other experimental drug within 2 weeks of study entry. - Drugs with known nephrotoxic or hepatotoxic effects within 2 weeks of study entry. - Drugs known to cause neutropenia within 2 weeks of study entry. - Rifampin or rifampin derivatives, phenytoin, or barbiturates within 2 weeks of study entry. - Any other medication except oral nonabsorbable antifungal agents within 72 hours of study entry. All medications, including aspirin, must be approved by investigator. All medications, including aspirin, must be approved by investigator. Patients must demonstrate the following clinical and laboratory findings: - AIDS, AIDS related complex (ARC), or persistent generalized lymphadenopathy as defined by the CDC classification. - No ascites. - Off all medications except oral antifungal, nonabsorbable agents for 72 hours prior to study entry.
Total Enrollment: 12
Location and Contact Information:
Overall Study Official:
LietmanP, Study Chair,
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Additional Information:
Study ID Numbers: ACTG 011;
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000997
Other Hiv Infections Studies:
1. Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs
2. A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea
3. HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults
4. A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection
5. A Comparison of Zidovudine (AZT) Used Alone or in Combination with Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
A Study of Dideoxycytidine in HIV-Infected Patients
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