To compare the durability of the viral load response following 48 weeks of treatment with 1592U89/lamivudine (3TC)/zidovudine (ZDV) versus 3TC/ZDV alone. To compare the early antiviral activity following 16 weeks treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone as demonstrated by the proportion of subjects with viral load \< 400 copies/ml, plasma HIV-1 RNA profiles and CD4+ profiles. To assess the safety and tolerance following 16 and 48 weeks of treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone.
This study compares the safety and efficacy of 1592U89 in combination with 3TC and ZDV versus control therapy with 3TC and ZDV alone. If a patient has two consecutive HIV-1 RNA measurements of \>= 400 copies/ml (performed at least one week apart) he or she has the option to switch to open-label therapy with 1592U89/3TC/ZDV, to receive the remaining randomized treatment, or to discontinue study medication. If this criterion is not met, patients continue their randomly assigned therapy until the last patient has completed 48 weeks of therapy. Once patients enter the open-label phase, investigators may add or substitute non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors, or protease inhibitors for 3TC and/or ZDV according to their standard practice once patients enter the open-label phase.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
210
East Bay AIDS Ctr
Berkeley, California, United States
Kraus Med Partners
Los Angeles, California, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Univ of Miami Dept of Medicine
Miami, Florida, United States
Rush Med College / Rush Presbyterian - St Luke's Med Cen
Chicago, Illinois, United States
Boston Med Ctr / Evans - 556
Boston, Massachusetts, United States
Saint Michael's Med Ctr / Dept of Infectious Diseases
Newark, New Jersey, United States
St Vincent's Hosp and Med Ctr / AIDS Ctr
New York, New York, United States
Harlem Hosp
New York, New York, United States
Duke Univ Med Ctr / Dept of Medicine
Durham, North Carolina, United States
...and 5 more locations
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