Safety and Effectiveness of Treating HIV-Positive Patients With an HIV Vaccine (Remune)
Safety and Effectiveness of Treating HIV-Positive Patients With an HIV Vaccine (Remune)
The purpose of this study is to see if giving HIV-positive patients an HIV vaccine plus
 anti-HIV drugs can help lower HIV levels in the blood (viral load).
At the time of study entry, all patients are receiving a HAART regimen consisting of three
 drugs from at least two classes of antiretroviral drugs. Upon entering the study, patients
 receive Remune or IFA at Weeks 0, 12, and 24. Patients remain on study for 40 weeks. Patients
 who have received three injections of Remune or IFA and whose plasma HIV-1 RNA level is less
 than 50 copies/ml at Week 26 discontinue HAART at Week 28. (If the patient has a plasma HIV-1
 RNA level at or above 50 copies/ml at Week 26, he/she must have a measurement below 50
 copies/ml at Week 27 to proceed with HAART discontinuation at Week 28. If by Week 27 the
 patient does not have a plasma HIV-1 RNA level below 50 copies/ml, the patient does not
 discontinue HAART but remains on study and has study visits at Weeks 34 and 40.) Patients who
 discontinue HAART have their plasma HIV-1 RNA levels measured on the day HAART is
 discontinued and at Days 3, 5, 7, 10, 14, 21, 28, 35, and 42 after discontinuation. Patients
 with a plasma HIV-1 RNA level of at least 5,000 copies/ml at Week 34 restart HAART at that
 time. (Patients whose plasma HIV-1 RNA level reaches greater than or equal to 100,000
 copies/ml on two occasions before Week 34 have the option of restarting HAART immediately.)
 Patients whose plasma HIV-1 RNA level is less than 5,000 copies/ml at Week 34 do not restart
 HAART unless their level increases to at least 5,000 copies/ml. Patients who discontinue
 HAART are monitored intensively for the duration of the study. Patients have 27 visits if
 they stay on study until completion at Week 40.
Inclusion Criteria

 Patients may be eligible for this study if they:

 -  Are HIV-positive.

 -  Are receiving an anti-HIV drug combination that contains three drugs from at least two
 classes of anti-HIV drugs (such as protease inhibitors). Patients must have been
 receiving this drug combination for at least 6 months before study entry. Before
 beginning this drug combination, patients must have taken either no anti-HIV drugs or
 only one or two nucleoside analogues (NRTIs).

 -  Had a viral load between 5,000 and 100,000 copies/ml before beginning their current
 anti-HIV therapy.

 -  Have a viral load below 50 copies/ml while on their current anti-HIV therapy within 2
 weeks before study entry.

 -  Have a CD4 count greater than 350 cells/mm3 at the time of study entry.

 -  Are at least 13 years old (consent of parent or guardian required if under 18).