Perspective: Information, Inspiration and Advocacy for People Living with HIV/AIDS

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in the cell therapy group will receive 2 infusions of HIV-specific CTL (5 billion cells
per infusion); one after participating in the
study for 3 months and the second 3 months
later. The second infusion will be given with
a 5-day cycle of interleukin-2 (IL-2) delivered by subcutaneous (under the skin) injection. IL-2 may help support the cell's activity against HIV. For details on participating, call Susan Crockett at 617-278-3464.
HIV-specific CTLs may be very important
in controlling HIV immediately after initial
infection. Some studies suggest that people
with initial strong and persistent HIV-specific cell responses are more likely to be
long-term non-progressors. Other studies,
however, suggest that even though there is
an increase in CD8+ cell number in people
with HIV, these cells never control HIV well.
Thus, capitalizing on what is known about

the immune system's response to HIV and
how it controls the virus, HIV-specific CTL
therapy may provide the immune system
with additional support by training the
CD8+ cells to better control the virus.
Two previous studies, done before protease
inhibitors became available, used smaller
numbers of cells per infusion and no IL-2.
Preliminary results from these studies show
that there are no side effects associated with
cell infusion, either during or following the
infusion. Participants experienced increases
in CD4+ cells and decreases in HIV RNA
levels, but these changes were not sustained
over time. Tests showed an increase in HIVspecific CTL activity which was sustained
for up to 8 months, however. Side effects
seen with IL-2 include fevers, rash and flulike symptoms, and can be managed with
the use of ibuprofen and antihistamines. For

information on IL-2 and managing its side
effects, call the Project Inform Hotline at
800-822-7422 for the new IL-2 Fact Sheet.
Educating Cells
A study at Stanford University is attempting to educate cells outside the body to recognize HIV. The study involves HIV-negative and positive family members. Cells are
removed from HIV-negative volunteers and
educated in a test tube environment to recognize HIV. Once they have been trained
to be HIV-specific, they are infused into the
HIV-positive family member. Preliminary
data from the first 5 volunteers suggest that
the procedure is safe, with no measurable
side effects during or after the infusion of
the HIV-specific cells. An increase in HIVspecific cell activity was seen in volunteers
with CD4+ counts greater than 400, sug
Oxandrolone for Weight Gain
Oxandrolone (Oxandrin@) is an oral drug used to promote
weight gain in people experiencing weight loss for which there
is no known cause (e.g. parasitic, viral, bacterial infections),
including HIV-associated weight loss.

Oxandrolone is approved by the Food and
Drug Administration although the studies
which supported its approval were conducted upwards of 30 years ago and the
usefulness of this drug in HIV is unknown
and is only now being researched.
Oxandrolone is a synthetic (man-made),
anabolic steroid. 'Anabolic' refers to the
ability of this type of drug to promote lean
body mass (anabolism). However, it is not
recommended as therapy for treating low
testosterone levels (hypogonadism).
Several small studies in people with HIVassociated weight loss have reported encouraging data when doses two to eight times
higher than the approved dose were used.
One study, conducted by Dr. Dietriech in
New York, enrolled 21 people who had lost
more than 5% their usual weight or who
weighed less than their ideal body weight.
This is not a standard definition for wasting syndrome, which is typically a weight
loss of 5 - 10% below ideal body weight.
The dose used was 10 mg twice daily, for a
total daily dose of 20 mg. People treated
for 30 days experienced a mean weight gain
of 6.5 lbs, those treated for 180 days saw
an 18.7 lbs increase. For those on therapy
for 1 year, there was a mean increase in
weight of 20.5 lbs. Those treated for 30
days saw an increase in the percent ideal
body weight from 91.9% to 95.9% and

those treated for 1 year went from 88.9% 1
ideal body weight, to 102%, just slightly
above 'ideal.' Because this study was not
placebo-controlled, it is difficult to understand the contributions of antiretroviral
therapy and other medications on the
weight gain realized by the studyaparticipants. In previous studies of oxandrolone
in people with HIV, lower doses showed
no appreciable effect on weight gain.
Another study, still ongoing in Texas, has
enrolled 20 women with HIV to evaluate I
two doses of oxandrolone, 10 and 20 mg
daily, in conjunction with nutritional support and resistance training. Early data suggest that after 7 weeks there was an average increase in body weight of 7 lbs. Interestingly, nutritional assessments showed B
vitamin and calcium deficiencies common
among these women who either had wasting syndrome or classic body composition
changes which indicate wasting syndrome.
Again, this study is not controlled and other
studies have shown that when nutritional
support and weight maintenance programs
are initiated, individuals tend to increase
weight and have improved quality of life.
The contribution of the drug to this improved weight gain is still unknown.
Side effects of anabolic steroids include
breast enlargement, acne, prostate/urinarytract infections, abnormal hair growth, ex
cessive frequency and duration of erections,
fluid or salt retention, nausea, jaundice,
changes in sex drive, reduced fertility, hardening of the arteries, headache, anxiety, depression, shrinking of the testicles, and allergic reactions. There are many womenspecific side effects associated with use of
anabolic agents, including clitoral enlargement, menstrual irregularities, deepening of
voice, hair loss, acne and changes in sex
drive. While these side effects may also be
associated with oxandrolone, they are seen
less frequently than with testosterone and
other non-synthetic anabolic agents.
Daily dosestranging from 20 to 80 mgwmay
be ideal for treating HIV-associated wasting syndrome, and large studies evaluating
different doses are currently ongoing. Despite aggressive advertising and marketing
by the company developing this drug, the
risks and benefits of oxandrolone therapy
in HIV remain unknown. It would not be
surprising, however, to see improved weight
gain in HIV with these higher doses. The
advantage of oxandrolone is that it is an
oral anabolic agent and most other therapies (e.g., testosterone therapy, human
growth hormone [Serostim~]) are injected.
Also, liver toxicity seen with anabolic steroid use does not appear to be a problem
with oxandrolone and the other synthetic
injectable hormone, nandrolone. Other
pharmaceutical weight gain therapies, including dronabinol (Marinol@) and megestrol
(Megace@) seem to promote weight gain in
the form of body fat, rather than lean body
mass (muscle). For more information on
devising a nutrition and weight maintenance
strategy, call the Project Inform Hotline at
800-822-7422. U

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