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.

Condition	Treatment or Intervention
HIV Infections	Drug: Lamivudine/Zidovudine  Drug: Nelfinavir mesylate  Drug: Aldesleukin

Following initial exposure to HIV, infection is established through the rapid replication of a homogeneous strain of the virus. Preliminary studies of combination antiretroviral therapy show that it is possible to reduce circulating HIV RNA to below detectable levels at this phase. Sustained suppression of viral replication or viral eradication may be possible only before HIV has become integrated in the immune system and undergone a number of quasi species mutations. This study will assess the feasibility of interrupting the natural course of HIV infection by using antiretroviral therapy soon after initial infection.

Nelfinavir (NFV) and zidovudine/lamivudine (Combivir) treatment starts as soon as possible and at most, 7 days from the diagnosis of HIV infection, and continues for 104 weeks. After 4 weeks of therapy patients are randomized to begin receiving IL-2 therapy or to delay starting it until Week 48. Patients may choose not to receive IL-2 treatment and remain in the study. Patients have clinic visits to measure viral load every 4 weeks. At a final clinic visit, physical examinations and collection of semen, cervical fluid, blood, and saliva specimens are done. Eligible consenting patients have a tonsil biopsy. Patients are reimbursed for participation in this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Rick Hecht      415-476-4071  Ext. 431    rhecht@sfaids.ucsf.edu

Alabama
      University of Alabama- Birmingham, Birmingham,  Alabama,  35294,  United States; Recruiting
California
      Rick Hecht, San Francisco,  California,  941102859,  United States; Recruiting

Study chairs or principal investigators

Jay Levy,  Principal Investigator

Study ID Numbers:  AIEDRP AI-01-001
Record last reviewed:  August 2004
Record first received:  November 3, 2000
ClinicalTrials.gov Identifier:  NCT00006441
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-10