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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Research Institute for Genetic and Human Therapy
• Treatments: Didanosine; Hydroxyurea; Stavudine

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.