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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002427
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 2000
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Hydroxyurea
Drug: Stavudine
Drug: Didanosine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 225
Study Start Date: May 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002427

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002427     History of Changes
Other Study ID Numbers: 304A, RIGHT 702
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Didanosine
Dose-Response Relationship, Drug
Drug Therapy, Combination
Stavudine
Hydroxyurea
Reverse Transcriptase Inhibitors
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Didanosine
Stavudine
Reverse Transcriptase Inhibitors
Hydroxyurea
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Antineoplastic Agents
Antisickling Agents
Hematologic Agents

ClinicalTrials.gov processed this record on April 15, 2014