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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: Indinavir sulfate; Drug: Efavirenz; Drug: Aldesleukin; Drug: Abacavir sulfate; Drug: Ritonavir; Drug: Didanosine; Drug: Stavudine

Study type: Interventional

Funder types: NIH

Identifiers

NCT00006154

CTN #124

11530 (Registry Identifier)

AI-07-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 165 estimated 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 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

A

Experimental group

Description:

Patients will receive combination antiretroviral therapy with a protease inhibitor

Treatment:

Drug: Didanosine

Drug: Ritonavir

Drug: Abacavir sulfate

Drug: Aldesleukin

Drug: Indinavir sulfate

B

Active Comparator group

Description:

Patients will receive combination antiretroviral therapy without a protease inhibitor

Treatment:

Drug: Didanosine

Drug: Stavudine

Drug: Abacavir sulfate

Drug: Efavirenz

Drug: Aldesleukin