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

NCT ID: NCT00006441

Last Updated: 2015-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2008-10-31

Brief 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.

Detailed 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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

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

Group Type: EXPERIMENTAL

Lamivudine/Zidovudine

Intervention Type: DRUG

300/150 mg respectively twice daily for 104 weeks. Patients who develop intolerence to AZT may use Stavudine (d4T) at a dose of 40 mg daily.

Nelfinavir mesylate

Intervention Type: DRUG

1250 mg twice daily for 104 weeks.

Aldesleukin

Intervention Type: DRUG

7.5 million units twice daily. Treatment will last until conclusion of study.

B

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

Group Type: ACTIVE_COMPARATOR

Lamivudine/Zidovudine

Intervention Type: DRUG

300/150 mg respectively twice daily for 104 weeks. Patients who develop intolerence to AZT may use Stavudine (d4T) at a dose of 40 mg daily.

Nelfinavir mesylate

Intervention Type: DRUG

1250 mg twice daily for 104 weeks.

Aldesleukin

Intervention Type: DRUG

7.5 million units twice daily. Treatment will last until conclusion of study.

Interventions

Lamivudine/Zidovudine

300/150 mg respectively twice daily for 104 weeks. Patients who develop intolerence to AZT may use Stavudine (d4T) at a dose of 40 mg daily.

Intervention Type: DRUG

Nelfinavir mesylate

1250 mg twice daily for 104 weeks.

Intervention Type: DRUG

Aldesleukin

7.5 million units twice daily. Treatment will last until conclusion of study.

Intervention Type: DRUG

Other Intervention Names

Combivir; NFV; IL-2

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiron Corporation

INDUSTRY

Sponsor Role: collaborator

Agouron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Glaxo Wellcome

INDUSTRY

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay Levy

Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama- Birmingham

Birmingham, Alabama, United States

Rick Hecht

San Francisco, California, United States

Countries

United States

Other Identifiers

AIEDRP AI-01-001

Identifier Type: -

Identifier Source: secondary_id

10435

Identifier Type: REGISTRY

Identifier Source: secondary_id

AI-01-001

Identifier Type: -

Identifier Source: org_study_id