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

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Lamivudine/Zidovudine; Drug: Aldesleukin; Drug: Nelfinavir mesylate

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00006441

AIEDRP AI-01-001

AI-01-001

10435 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 398 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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398 participants in 2 patient groups

A

Experimental group

Description:

Patients beginning IL-2 treatment regimens after 4 weeks of study

Treatment:

Drug: Nelfinavir mesylate

Drug: Aldesleukin

Drug: Lamivudine/Zidovudine

B

Active Comparator group

Description:

Patients beginning IL-2 treatment after some delay based on specified criteria

Treatment:

Drug: Nelfinavir mesylate

Drug: Aldesleukin

Drug: Lamivudine/Zidovudine