Effectiveness of Adding Interleukin-2 to Anti-HIV Drugs in Patients Recently Infected With HIV

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see whether taking interleukin-2 (IL-2) and other anti-HIV drugs affects the course of HIV disease in patients with primary HIV infection (the time period that immediately follows infection with HIV).

After primary HIV infection, the actual infection is spread through an increasing amount of HIV virus in the body. Studies have shown that, by taking a combination of anti-HIV drugs, it is possible to reduce the amount of HIV in the body to almost undetectable levels. This study will find out if starting anti-HIV drugs during primary infection will interrupt or reduce the spread of HIV in patients' bodies.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Agouron Pharmaceuticals; Chiron Corporation; Glaxo Wellcome
• Treatments: Aldesleukin; Interleukin-2; Lamivudine; Lamivudine, zidovudine drug combination; Nelfinavir; Zidovudine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Have recent HIV infection.

• Are available for follow-up for at least 96 weeks.

• Are at least 18 years old.

• Use a barrier method of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have a condition such as Epstein-Barr virus, CMV mononucleosis syndrome, or acute streptococcal pharyngitis.

• Have taken anti-HIV therapy for over 4 weeks.

• Have or have had cancer requiring chemotherapy or radiation therapy within 1 month of study entry and have not yet recovered from the effects.

• Abuse alcohol and other drugs.

• Are pregnant.

• Have a condition which interferes with intestinal absorption, such as severe diarrhea.