A Study to Evaluate the Use of a Protease Inhibitor and of Interleukin-2 (IL-2) in the Treatment of Early HIV Infection

NCT00006154 | Completed Phase 3

• 3 other identifiers: AI-07-001CTN #12411530
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to look at the effectiveness of combination anti-HIV drug therapy (with protease inhibitors \[PIs\] or without) in patients with early HIV infections. This study also looks at whether a drug called interleukin-2 (IL-2) can boost the immune system of these patients. Doctors are not sure which anti-HIV drug combination is best to use in patients who have early HIV infection and have never received anti-HIV treatment. PIs are anti-HIV drugs that decrease viral load (level of HIV in the blood). However, PIs can cause serious side effects in some patients. Doctors would like to know if a drug combination that does not contain a PI is just as good as one that contains PIs.

Conditions

HIV Infections

Keywords

Interleukin-2; Didanosine; Drug Therapy, Combination; Stavudine; HIV Protease Inhibitors; Ritonavir; Indinavir; Virus Latency; Reverse Transcriptase Inhibitors; Anti-HIV Agents; abacavir; efavirenz; Acute Infection

Outcome Measures

Primary Outcomes (4)

• Virologic: A. Plasma viral load B. Tissue viral load (CNS, lymphoid tissues, genital tract) C. HIV DNA (proviral) levels in circulating mononuclear cells D. Phenotypic and genotypic antiretroviral drug resistance

  Throughout study

• Immunologic: A. Evaluation of CD4, CD8, CD45RA, CD45RO phenotypes and defined activation markers B. Evaluation of the diversity and persistence of the T cell repertoire (CD4+, CD8+) in the circulation and lymphoid tissues

  Throughout study

• Immunologic: C. Functional CD4+ cellular assays (class II MHC tetramers) D. Thymic regeneration as studied by the exclusion circle assay E. Evolution of Western blot banding patterns F. Evolution of anti-HIV neutralizing antibody levels

  Throughout study

• Clinical: A. Minor opportunistic infections or AIDS-defining conditions B. Death C. Clinical or laboratory adverse events D. Evaluation of adherence to therapy E. Evaluation of lipodystrophy

  Throughout study

Study Arms (2)

A

EXPERIMENTAL

Patients will receive combination antiretroviral therapy with a protease inhibitor

Drug: Indinavir sulfate; Drug: Ritonavir; Drug: Abacavir sulfate; Drug: Didanosine; Drug: Aldesleukin

B

ACTIVE COMPARATOR

Patients will receive combination antiretroviral therapy without a protease inhibitor

Drug: Abacavir sulfate; Drug: Efavirenz; Drug: Stavudine; Drug: Didanosine; Drug: Aldesleukin

Interventions

Indinavir sulfate DRUG

400 mg tablets equaling 1600 mg daily

Also known as: IDV

A

Ritonavir DRUG

100 mg liquid capsules equaling 400 mg daily

Also known as: RTV

A

Abacavir sulfate DRUG

300 mg capsules equaling 600 mg daily. Administration based on individual results after 16 weeks.

Also known as: ABC

A; B

Efavirenz DRUG

200 mg capsules equaling 600 mg daily

Also known as: DMP

B

Stavudine DRUG

30-40 mg capsules equaling 60 or 80 mg daily

Also known as: d4T

B

Didanosine DRUG

250-400 mg E.coated tablets equaling 250 or 400 mg daily

Also known as: ddI

A; B

Aldesleukin DRUG

Subcutaneous injection equaling 15 x 10\^6 IU daily dose. Administration based on individual results after 16 weeks and randomization.

Also known as: Proleukin, IL-2

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be eligible for this study if they:
• Have been infected recently with HIV. This will be determined by certain lab tests.
• Are 18 years of age or older.
• Are able to swallow a large number of pills.
• Are willing to use barrier methods of birth control (such as condoms) during the study.

You may not qualify if:

• Patients will not be eligible for this study if they:
• Abuse drugs or alcohol.
• Have any condition that, in the opinion of the investigator, could impair their ability to participate in the study.
• Are breast-feeding or pregnant.
• Have received any prior anti-HIV drugs. (However, use of anti-HIV drugs to try to prevent infection more than 6 months prior to study entry is allowed.)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (4)

Viridae Clinical Sciences / University of British Columbia

Vancouver, British Columbia, Canada

Location

Centre de traitment d'immunodeficience

Montreal, Quebec, Canada

Location

Centre Hospitalier de la Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Location

Institut Thoracique de Montreal

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Indinavir; Ritonavir; abacavir; efavirenz; Stavudine; Didanosine; aldesleukin; Interleukin-2

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Rafick-Pierre Sekaly

  PRINCIPAL INVESTIGATOR

• Brian Conway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2000
• First Posted: August 31, 2001
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

CA (4)