To determine if Thalidomide modulates the production of HIV-suppressor factors (MIP-1 alpha,
MIP-1 beta, Rantes) and TH1 type cytokines (IL-12 and INF-gamma) in HIV-infected patients
and alters viral load.
Patients will be divided, 5 per group, into Groups I, II, III and IV. Groups I and II will
include patients who have decided not to take anti-retro viral drugs. Groups III and IV will
include patients receiving the same types of antiretroviral drugs. Patients in groups I and
III will receive thalidomide while patients in group II and IV will receive placebo. The
placebo capsules will be the same color as the thalidomide capsules and will contain glucose
powder. Patients will ingest one capsule of thalidomide at 9 PM daily on days 0, 1, 2, 3, 4,
5 and 6.
Patients must have:
- HIV infection.
- CD4+ cell count >= 200/microliter or > 14% CD4+ cells in peripheral blood.
- Willingness to commit to the study duration and agree to abide to the time table for
entry into the study, ingestion of thalidomide and follow-up.
Patients with any of the following conditions or symptoms are excluded:
- Fertile females.
- Patients who participated in a clinical study involving a new drug or device within
the last 2 months or the period of time equivalent to seven times the half life of
the study drug, whichever is longer.
Patients with any of the following prior conditions are excluded:
HIV related pre-existing peripheral neuropathy.
Patients using systemic steroidal anti inflammatory drugs or pentoxifylline within 10 days
of dosing with thalidomide.
10 of the 20 patients must be on antiretroviral therapy and the other 10 will be subjects
who have decided not to be on any antiretroviral drug prior to enrollment into this study
and do not plan to start such treatment during the study period.