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

NCT ID: NCT00006154

Last Updated: 2013-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Studies have suggested that an antiretroviral drug regimen of the non-nucleoside agent efavirenz (EFV) in combination with two nucleoside analogues is effective at achieving maximal viral suppression. This provides an alternative treatment to that of the more toxic PI-containing regimen. This trial examines whether a nonPI regimen with EFV is more beneficial than a PI-containing regimen when each is used in combination with the same two nucleoside analogues. A second part of the study looks at whether the addition of IL-2 may offer immunologic benefits as a co-administered drug.

Patients are randomized to initiate antiretroviral therapy of a PI-based (stavudine/didanosine/ritonavir \[RTV\]/indinavir \[IDV\]) or nonPI-based (stavudine/didanosine/EFV) regimen. Within these treatment arms, they are stratified according to a positive or negative p24 antigen result. At Week 16, patients not achieving maximal viral suppression (lower than 50 copies/ml) have the option to add abacavir (ABC) or other drugs as intensification therapy. Those achieving virologic suppression (less than 50 copies/ml) are randomized either to receive IL-2 or not. At study entry, and after 12 months, tissue samples of CSF, lymph node, and genital secretions are obtained, with permission. Patients have physical exams, women of child-bearing potential have pregnancy tests, and blood samples are drawn at clinic visits 12-16 times a year over 3 years so that virologic and immunologic evaluations may be performed. Compensation for time and transportation is given.

Conditions

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HIV Infections

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Patients will receive combination antiretroviral therapy with a protease inhibitor

Group Type EXPERIMENTAL

Indinavir sulfate

Intervention Type DRUG

400 mg tablets equaling 1600 mg daily

Ritonavir

Intervention Type DRUG

100 mg liquid capsules equaling 400 mg daily

Abacavir sulfate

Intervention Type DRUG

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

Didanosine

Intervention Type DRUG

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

Aldesleukin

Intervention Type DRUG

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

B

Patients will receive combination antiretroviral therapy without a protease inhibitor

Group Type ACTIVE_COMPARATOR

Abacavir sulfate

Intervention Type DRUG

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

Efavirenz

Intervention Type DRUG

200 mg capsules equaling 600 mg daily

Stavudine

Intervention Type DRUG

30-40 mg capsules equaling 60 or 80 mg daily

Didanosine

Intervention Type DRUG

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

Aldesleukin

Intervention Type DRUG

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

Interventions

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Indinavir sulfate

400 mg tablets equaling 1600 mg daily

Intervention Type DRUG

Ritonavir

100 mg liquid capsules equaling 400 mg daily

Intervention Type DRUG

Abacavir sulfate

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

Intervention Type DRUG

Efavirenz

200 mg capsules equaling 600 mg daily

Intervention Type DRUG

Stavudine

30-40 mg capsules equaling 60 or 80 mg daily

Intervention Type DRUG

Didanosine

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

Intervention Type DRUG

Aldesleukin

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

Intervention Type DRUG

Other Intervention Names

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IDV RTV ABC DMP d4T ddI Proleukin IL-2

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rafick-Pierre Sekaly

Role: PRINCIPAL_INVESTIGATOR

Brian Conway

Role: PRINCIPAL_INVESTIGATOR

Locations

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Viridae Clinical Sciences / University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Centre de traitment d'immunodeficience

Montreal, Quebec, Canada

Site Status

Centre Hospitalier de la Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Site Status

Institut Thoracique de Montreal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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CTN #124

Identifier Type: -

Identifier Source: secondary_id

11530

Identifier Type: REGISTRY

Identifier Source: secondary_id

AI-07-001

Identifier Type: -

Identifier Source: org_study_id