Interleukin-2 Therapy for HIV Infection - Supplemental Procedures
Status:
Completed
Trial end date:
2002-03-01
Target enrollment:
Participant gender:
Summary
Certain patients who are participating in NIH protocols involving interleukin-2 (IL-2)
therapy for HIV disease may be requested to have the following changes or additions to their
study protocol:
- 3-day subcutaneous (sc) IL-2 administration: Patients currently receiving IL-2
intravenously (injections through a vein) may switch to subcutaneous administration
(injections under the skin). Injections are given twice a day for 3 to 5 days (one
treatment cycle), with cycles repeated no more often than every 8 weeks.
- Home treatment of sc IL-2: Home administration of IL-2 injections involves less frequent
data and safety monitoring and no medical evaluations at the Clinical Center except at
the beginning of each cycle. Participants will receive IL-2 cycles on the same schedule
they followed in their original protocol. They will be seen at the Clinical Center at
regularly scheduled follow-up visits between cycles and for a medical evaluation and
blood drawing before the start of each cycle to determine the safety of administering
the next cycle. During the home cycle, the patient's case manager or other team member
will place monitoring telephone calls on days 2 and 4 of the cycle and again a week
later. The timing and number of these calls may change depending on the findings of
ongoing assessments of their usefulness. Patients will be required to notify the study
team promptly of complications or other problems that develop with therapy.
- Stored specimens and HLA testing: Stored blood and tissue samples from patients will be
used for future research on HIV, AIDS and related medical conditions, and the immune
system. The samples may be labeled with no identifying information, with identifying
information, such as the patient's name, or with a code that only the study team can
link to the patient. Some of the blood drawn may be used for HLA typing, a genetic test
of markers of the immune system. Usually used to match bone marrow or organ transplants,
HLA type might also be used to try to identify factors associated with the progression
of HIV disease or related conditions. Determining HLA type is also necessary to be able
to perform certain research studies.
- Tonsillar biopsy: Examination of tonsil tissue may provide information on the effects of
IL-2 on the immune system and the expression of HIV. Patients in the randomized IL-2
study (93-CC-0113) may have tonsillar biopsies done up to three times-soon after
enrollment, after month 4, and after month 12. Patients in the open IL-2 study
(91-CC-0143) would have procedures no more often than every 3 months, with the following
exception: patients in either study who are willing to have repeat biopsies performed
during IL-2 therapy will have the procedure done up to three times during a round of
IL-2: before Il-2 therapy, day 2-3 or IL-2 therapy, and day 4-6 of IL-2 therapy, if the
sequential biopsies can be safely performed. The area to be biopsied will be numbed with
a local anesthetic and 1 to 2 small pieces of tissue will be biopsied.
- Skin biopsy: Examination of skin tissue may help to explain how IL-2 causes changes in
the skin. Biopsies will be obtained from areas of the skin that have been affected by
IL-2 as well as from normal, unaffected areas for comparison. Patients with Kaposi
sarcoma will also have biopsies of normal skin to allow comparison with IL-2-induced
changes in the Kaposi sarcoma lesions. The areas to be biopsied will be numbed with
local anesthetic and a 2-mm (1/10th-inch) piece of skin will be biopsied from each site.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)