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

NCT00002427 | Completed Phase 1

• 2 other identifiers: 304ARIGHT 702
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

HIV Infections

Keywords

Didanosine; Dose-Response Relationship, Drug; Drug Therapy, Combination; Stavudine; Hydroxyurea; Reverse Transcriptase Inhibitors; Anti-HIV Agents

Interventions

Hydroxyurea DRUG

Stavudine DRUG

Didanosine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Institute for Genetic and Human Therapy: lead

Study Sites (18)

AIDS Healthcare Foundation

Los Angeles, California, 90027, United States

Location

San Francisco VA Med Ctr

San Francisco, California, 94121, United States

Location

Gary Blick MD

Stamford, Connecticut, 06901, United States

Location

Dr Bruce Rashbaum

Washington D.C., District of Columbia, 20037, United States

Location

IDC Research Initiative

Altamonte Springs, Florida, 32701, United States

Location

Boulevard Comprehensive Care Ctr

Jacksonville, Florida, 32209, United States

Location

Center for Quality Care

Tampa, Florida, 33609, United States

Location

AIDS Research Consortium of Atlanta Inc

Atlanta, Georgia, 30308, United States

Location

New England Med Ctr

Boston, Massachusetts, 02111, United States

Location

Albany Med College

Albany, New York, 122083479, United States

Location

Mt Vernon Hosp

Mount Vernon, New York, 10550, United States

Location

Univ of Pennsylvania Med Ctr

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson Univ

Philadelphia, Pennsylvania, 19107, United States

Location

Coastal Carolina Research Ctr

Mt. Pleasant, South Carolina, 29464, United States

Location

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, 75235, United States

Location

Univ of Texas Med Branch

Galveston, Texas, 775550835, United States

Location

Montrose Clinic

Houston, Texas, 77006, United States

Location

Swedish Med Ctr

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Hydroxyurea; Stavudine; Didanosine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides

Study Officials

• Franco Lori

  STUDY CHAIR

• Julianna Lisziewicz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Start: May 1, 1999
• Last Updated: June 24, 2005

Record last verified: 2000-08

Locations

US (18)