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

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.

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.)