Search / Trial NCT00002427

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

Launched by RESEARCH INSTITUTE FOR GENETIC AND HUMAN THERAPY · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Didanosine Dose Response Relationship, Drug Drug Therapy, Combination Stavudine Hydroxyurea Reverse Transcriptase Inhibitors Anti Hiv Agents

ClinConnect Summary

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 prio...

Gender

ALL

Eligibility 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.

Trial Officials

Franco Lori

Study Chair

Julianna Lisziewicz

Study Chair

About Research Institute For Genetic And Human Therapy

The Research Institute for Genetic and Human Therapy (RIGTH) is a leading organization dedicated to advancing the field of genetic research and therapeutic development. With a focus on innovative approaches to treat genetic disorders and improve human health, RIGTH collaborates with academic institutions, healthcare providers, and industry partners to conduct cutting-edge clinical trials. The institute is committed to translating scientific discoveries into effective therapies, ensuring rigorous adherence to ethical standards and regulatory compliance. Through its multidisciplinary expertise and state-of-the-art facilities, RIGTH aims to pioneer breakthroughs that enhance patient outcomes and contribute to the global understanding of genetic medicine.

Locations

Boston, Massachusetts, United States

Dallas, Texas, United States

Philadelphia, Pennsylvania, United States

Galveston, Texas, United States

Altamonte Springs, Florida, United States

Washington, District Of Columbia, United States

Los Angeles, California, United States

Mount Pleasant, South Carolina, United States

Seattle, Washington, United States

Houston, Texas, United States

Mt. Vernon, New York, United States

Albany, New York, United States

Philadelphia, Pennsylvania, United States

Jacksonville, Florida, United States

Atlanta, Georgia, United States

San Francisco, California, United States

Tampa, Florida, United States

Stamford, Connecticut, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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