a study to evaluate the use of a protease inhibitor and of interleukin-2 (il-2) in the treatment of early hiv infection

Conditions: HIV Infections

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.

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.

Eligibility 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.)

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