A Study of Dideoxycytidine in HIV-Infected Patients

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000997

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Zalcitabine	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pharmacokinetics and Bioavailability of Dideoxycytidine in Patients With Human Immunodeficiency Virus Infection

Actual Study Completion Date :

Dec 1, 1988

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.