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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002427

Run by

Research Institute for Genetic and Human Therapy

People needed

225

Starts

1999-05-01

Last updated by the study team

2005-06-24

Who can join

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

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.

Where it is running

• AIDS Healthcare Foundation — Los Angeles, California, United States
• San Francisco VA Med Ctr — San Francisco, California, United States
• Gary Blick MD — Stamford, Connecticut, United States
• Dr Bruce Rashbaum — Washington D.C., District of Columbia, United States
• IDC Research Initiative — Altamonte Springs, Florida, United States
• Boulevard Comprehensive Care Ctr — Jacksonville, Florida, United States
• Center for Quality Care — Tampa, Florida, United States
• AIDS Research Consortium of Atlanta Inc — Atlanta, Georgia, United States
• New England Med Ctr — Boston, Massachusetts, United States
• Albany Med College — Albany, New York, United States
• Mt Vernon Hosp — Mount Vernon, New York, United States
• Univ of Pennsylvania Med Ctr — Philadelphia, Pennsylvania, United States
• Thomas Jefferson Univ — Philadelphia, Pennsylvania, United States
• Coastal Carolina Research Ctr — Mt. Pleasant, South Carolina, United States
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Univ of Texas Med Branch — Galveston, Texas, United States
• Montrose Clinic — Houston, Texas, United States
• Swedish Med Ctr — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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