Effectiveness of Early or Delayed Addition of Hydroxyurea to a Three-Drug Anti-HIV Drug Combination Including Didanosine, in Advanced HIV Patients Who Failed a First or Second Anti-HIV Triple-Drug Therapy

Inclusion Criteria

Patients may be eligible for this study if they:

• Are at least 13 years old.
• Have the signed consent of parent/guardian if under 18 years of age.
• Are HIV-positive.
• Have failed 1 or 2 anti-HIV drug combination therapies which had at least 3 anti-HIV drugs each.
• Have been on stable, triple anti-HIV drug therapy for at least 16 weeks prior to study entry.
• Have a CD4 count under 300 cells/mm3 within 45 days prior to study entry.
• Agree not to become pregnant or make anyone else pregnant while on study drugs and for 60 days after stopping drugs.
• Agree to use 2 methods of birth control while on study drugs and for 60 days after stopping study drugs.
• Have a negative pregnancy test within 14 days prior to study entry.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Received treatment for a serious infection or illness that was completed less than 2 weeks prior to study entry or, if they are still receiving treatment, he/she must have been clinically stable for at least 14 days prior to study entry.
• Are pregnant or breast-feeding.
• Are using any drugs that affect the immune system, other than those specified by the study.
• Received an immunization within 30 days prior to study entry.
• Have had pancreatitis.
• Have severe neuropathy (a condition affecting the nervous system).
• Received granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to study entry.
• Abuse alcohol or drugs.
• Have any medical condition that would make the patient unable to complete the study.
• Have used hydroxyurea within 24 weeks prior to study entry.
• Had hepatitis within 60 days of study entry.