Safety and Effectiveness of an Anti-HIV Drug Combination With and Without Hydroxyurea in Patients With Early HIV Infection

• Status: Withdrawn
• 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 an anti-HIV drug combination with and without hydroxyurea in patients with early HIV infection.

Certain combinations of anti-HIV drugs have been effective in lowering levels of HIV in the blood and keeping them down. However, these treatments are not effective in some patients. This study will see if using a combination containing more drugs will help in patients with early HIV infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Didanosine; Hydroxyurea; Indinavir; Ritonavir; Stavudine

Criteria

Inclusion Criteria

Patient may be eligible if they:

• Are in the early stages of HIV infection.

• Are at least 13 years old (consent of parent or guardian required if under 18).

• Agree to use 2 barrier methods of birth control (such as condoms) during the study and for 3 months after.

Exclusion Criteria

Patients will not be eligible if they:

• Have a liver or kidney problem (Group I only).

• Have a history of pancreatitis (Group I only).

• Have ever taken anti-HIV drugs before.

• Plan to take anti-HIV drugs other than the study drugs during the study. (Study drugs may be substituted if the investigator finds it necessary.)

• Have had radiation treatment within 30 days prior to study entry.

• Have received chemotherapy or any experimental therapy within 30 days of study entry or plan to receive such therapies during the study.

• Have taken interferons, interleukins, colony-stimulating factors, and HIV vaccines within 30 days prior to study entry.

• Have taken certain other drugs.

• Are pregnant or breast-feeding.