The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To determine the safety and tolerability of hydroxyurea at two doses alone and in combination with didanosine (ddI). To compare the short term antiviral effect of ddI monotherapy versus hydroxyurea plus ddI, as measured by plasma RNA levels at 8 weeks of therapy. \[AS PER AMENDMENT 10/1/97: Accrual to arms involving hydroxyurea alone has been closed.\] Current antiviral therapies for HIV-1 are limited by a few choices, and the lack of sustained clinical benefit from the drugs. The mechanisms that account for the lack of prolonged inhibition of viral replication by these agents are not fully understood. The activity of RT inhibitors might be potentiated by inhibiting host cellular enzymes essential for efficient HIV reverse transcription. Based on this information, comparisons of the antiviral effects of ddI monotherapy and hydroxyurea plus ddI, with the cellular enzyme ribonucleotide reductase as a potential target, should be done.

Key facts

Study ID: NCT00001074
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 140
Expected to finish: 2000-01-01
Last updated by the study team: 2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Concurrent Medication:
Allowed:
AS PER AMENDMENT 5/5/97:
PCP prophylaxis with trimethoprim/sulfamethoxazole or Dapsone.
Patients must have:
HIV-1 infection.
AS PER AMENDMENT 5/5/97:
CD4 count of 200 - 700 cells/mm3 within 60 days prior to study entry.
AS PER AMENDMENT 10/1/97:
HIV RNA plasma level < 20,000 copies/ml within 60 days of enrollment (obtained at a laboratory certified to perform the Roche Monitor assay).

You may not qualify if…

Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
CMV, MAC, toxoplasmosis, or disseminated fungal infection requiring acute or chronic therapy.
Significant medical illness as determined by investigator.
Active diagnosis of any malignancy, including visceral Kaposi's sarcoma or extensive cutaneous Kaposi's sarcoma for which systemic chemotherapy is anticipated within the next 24 weeks.
Current Grade 2 or greater peripheral neuropathy.
Concurrent Medication:
Excluded:
Acute or chronic therapy for CMV, MAC, toxoplasmosis, or disseminated fungal infection.
AS PER AMENDMENT 5/5/97:
All antiretroviral medications other than those provided on study.
Systemic chemotherapy for active malignancies, including systemic treatment for KS.
Agents with myelosuppressive potential, including tegretol, carboplatin, carmustine, cyclophosphamide and fluorouracil.
Granulocyte colony stimulating factor (G-CSF) except while hydroxyurea or matching placebo is held.
Drugs associated with peripheral neuropathy, including:
hydralazine, disulfiram, nitrofurantoin, cisplatinum, diethyldithiocarbamate, gold, rifampin, chloramphenicol, clioquinol, ethambutol, ethionamide, glutethimide, sodium cyanate, and thalidomide.
Patients with any of the prior conditions are excluded:
History of transfusion dependent anemia, defined as any history of repeated transfusion with two or more units of red blood cells.
At the discretion of the investigator, history of pancreatitis.
Prior Medication:
Excluded:
More than 2 weeks prior treatment with ddI.
AS PER AMENDMENT 5/5/97:
Other antiretrovirals must be discontinued at least 14 days prior to randomization.
Prior hydroxyurea.

Where it is running

Univ of California / San Diego Treatment Ctr — San Diego, California, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr — San Francisco, California, United States
Stanford Univ Med Ctr — Stanford, California, United States
Harbor UCLA Med Ctr — Torrance, California, United States
Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
Johns Hopkins Hosp — Baltimore, Maryland, United States
Beth Israel Med Ctr — New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
Mount Sinai Med Ctr — New York, New York, United States
Univ of North Carolina — Chapel Hill, North Carolina, United States
Duke Univ Med Ctr — Durham, North Carolina, United States
Univ of Cincinnati — Cincinnati, Ohio, United States
Case Western Reserve Univ — Cleveland, Ohio, United States
MetroHealth Med Ctr — Cleveland, Ohio, United States
Univ of Pennsylvania at Philadelphia — Philadelphia, Pennsylvania, United States
Thomas Jefferson Univ Hosp — Philadelphia, Pennsylvania, United States
Julio Arroyo — West Columbia, South Carolina, United States
Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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