The purpose of this study is to see if it is effective to add an HIV vaccine (Remune) to the
anti-HIV drug combination of Combivir (zidovudine plus lamivudine) and nelfinavir.
All patients begin HAART at study entry (Day 1). Patients with a plasma HIV-1 RNA level less
than or equal to 2,000 copies/ml at Week 8 are randomized to receive Remune or Incomplete
Freund's Adjuvant (IFA) at Week 9. Patients who do not achieve a plasma HIV-1 RNA level of
less than or equal to 2,000 copies/ml at Week 8 are not randomized and are terminated from
the study. These patients are eligible to receive funding for up to a 3-month supply of
nelfinavir (Viracept) and Combivir. Randomized patients receive Remune or IFA at Week 9 and
approximately every 12 weeks thereafter until study completion (when the last patient
reaches Week 48). Patients are considered virologic failures if they (1) fail to achieve a
virologic response by Week 48 or (2) after achieving a virologic response, have a virologic
relapse. Regardless of their previous response status, patients whose plasma HIV-1 RNA level
increases to greater than 2,000 copies/ml while they are receiving protocol-specified HAART
are eligible to receive salvage therapy and continue to receive Remune or IFA until study
completion. Study visits occur at screening, Day 1, Weeks 4, 8, 9, 12, and then every 4
weeks thereafter until the last patient reaches Week 48. Patients who complete this study
are eligible to participate in a rollover study.
Patients may be eligible for this study if they:
- Are HIV-positive.
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Have a viral load of at least 10,000 copies/ml.
- Have a CD4 count of at least 250 cells/mm3.
- Have never taken any anti-HIV drugs before.