A Study of Dideoxycytidine in HIV-Infected Patients

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Zalcitabine

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000997

ACTG 011

10987 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.