Safety and Effectiveness of Combining Hydroxyurea (HU) With Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults

June 23, 2005 updated by: Research Institute for Genetic and Human Therapy

A Phase I/II Study of the Safety and Antiretroviral Activity of Nine Hydroxyurea Regimens in Combination With ddI and d4T in Subjects With HIV Infection

The purpose of this study is to compare the safety and effectiveness of 9 doses of HU in order to find the best dose of HU to use with ddI and d4T in fighting HIV infection.

HU plus ddI plus d4T appears to be a suitable anti-HIV drug combination for long-term control of HIV. This combination can sharply decrease viral load (level of HIV in the body) with few side effects, making it easy to take.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The combination of HU plus ddI plus d4T appears to be suitable for long-term control of HIV in that it: (1) has a novel resistance/rebound profile demonstrating virus suppression even in the presence of ddI-resistant mutants; (2) can produce a pronounced fall in viral load; and (3) is well tolerated (over 200 patients have been treated for up to 3 years with minimal side effects).

Patients are stratified by antiretroviral experience: naive (no more than 2 weeks of therapy) versus experienced (more than 2 weeks). Patients must discontinue all antiretroviral therapy for at least 28 days prior to randomization to 1 of 9 HU treatment arms. Treatment arms are divided into 3 HU dose categories: very low, low, and medium. Within each category HU is administered daily on 3 different dosing schedules. Depending on viral load, patients on the very low and low dose arms may have the opportunity to intensify their HU dose at any time beyond Week 12, provided no Grade 3 or 4 HU-related toxicity is present (these patients are monitored for an additional 8 weeks following intensification). All patients receive ddI and d4T at the same doses every day. When 50% of patients have completed 24 weeks of treatment, an analysis is made to determine whether or not to continue the 52-week study without modifications. Patients are monitored periodically for changes in plasma HIV RNA, CD4 cell counts, weight, and symptoms.

Study Type

Interventional

Enrollment

225

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • AIDS Healthcare Foundation
      • San Francisco, California, United States, 94121
        • San Francisco VA Med Ctr
    • Connecticut
      • Stamford, Connecticut, United States, 06901
        • Gary Blick MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Dr Bruce Rashbaum
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • IDC Research Initiative
      • Jacksonville, Florida, United States, 32209
        • Boulevard Comprehensive Care Ctr
      • Tampa, Florida, United States, 33609
        • Center for Quality Care
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta Inc
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Med Ctr
    • New York
      • Albany, New York, United States, 122083479
        • Albany Med College
      • Mt. Vernon, New York, United States, 10550
        • Mt Vernon Hosp
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson Univ
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ of Pennsylvania Med Ctr
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Ctr
    • Texas
      • Dallas, Texas, United States, 75235
        • Univ of Texas Southwestern Med Ctr of Dallas
      • Galveston, Texas, United States, 775550835
        • Univ of Texas Med Branch
      • Houston, Texas, United States, 77006
        • Montrose Clinic
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Med Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have a viral load of 5,000 to 100,000 copies/ml.
  • Are willing to stop all anti-HIV medications for at least 28 days before receiving study drugs.
  • Are at least 18 years old.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have a history of opportunistic (AIDS-related) infection.
  • Have a history of pancreatitis or other serious condition.
  • Have any cancer that will require chemotherapy within the next 24 weeks.
  • Are allergic to ddI or d4T.
  • Have received an HIV vaccine within 28 days of study entry.
  • Have received a red blood cell transfusion within the past 60 days, or have had repeated transfusions at any time in the past.
  • Abuse alcohol or drugs.
  • Have received certain medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Factorial Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Institute for Genetic and Human Therapy

Investigators

  • Study Chair: Franco Lori
  • Study Chair: Julianna Lisziewicz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1999

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

August 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 304A
  • RIGHT 702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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