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A5241:
The OPTIONS Study: A Study For People Whose HIV
medicines Are Not Working to Control Their Viral
Load.
Brief
Description:
This study will look at whether newer anti-HIV drugs
are safe and effective in a group of HIV- infected
persons whose current HIV medicines are not working
and whether using a specific type of medicines,
nucleoside reverse transcriptase inhibitors (NRTIs),
are needed to treat persons failing their current
medicines. This
study will also look to see whether a medicine
resistance test scoring system called cPSS
(continuous phenotype susceptibility score) is able
to predict which drugs will work best in people
whose virus is resistant to specific HIV
medications.
Major
Requirements to Enter Study:
Part One:
Selecting your new medicines.
Part one of the study may last up to 60 days.
Step A: New
HIV Medicines. When
you first enter the study, you
will remain on your current HIV medicines while the
study physicians review your resistance testing,
your cPSS score and the type of virus that you have,
as well as your previous medication history. The
study physicians will recommend to you and your
primary physician one or more new HIV medicine
regimens that will give a cPSS test score above 2.
Some of the recommended medicines may need to
be taken by injection.
If there are two or more combinations that
may work for you, your primary doctor and you will
pick one. If the study physicians and your primary
doctor cannot choose a study drug combination that
will give a cPSS score above 2, you might enter part
two of the study.
Step B:
NRTIs or no NRTIs.
When the study physicians recommend the
possible new HIV drugs combinations to your primary
physician and you, they will also recommend a
combination of NRTIs based on the results of the
resistance testing. Again, if there is more than one
possible NRTIs combination choice, your primary
doctor and you will be able to pick one you might
take. However,
only one-half of the people in the study will take
the NRTI medicines along with their new HIV medicine
regimen. Whether
you include NRTIs in your new HIV medicine regimen
will be decided through randomization (chosen as if
by a flip of a coin).
Part Two:
Monitoring your health while taking the new
medicines. Part
two of the study will last 48 weeks. During
part two of
the study, you will receive your medicines and
return to the clinic at least 8 times for a health
check up. At
these visits your HIV viral load and CD4 cell count
will be tested. If the new drugs do not work to make
your viral load low enough, you will have another
resistance test done as part of the study; results
of these tests will be given to your primary doctor.
Study Drugs The
anti-HIV drugs that will be provided through the
study are: enfuvirtide,
raltegravir, darunavir, tipranavir, etravirine and
maraviroc. Which
of these drugs are recommended for you depends on
the results of the testing done in the Part One of
the study. Although
they may be recommended by the study doctors, NRTIs
and ritonavir will not be provided through the
study.
Length
of Study:
The study will last approximately 14 months (a
little over one year).
Compensation: You will be
compensated for two study visits.
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Cytheris
107: Identification
of a biologically active dose of
Interleukin-7 CYT107 in patients on
HAART with viral suppression but
inadequate CD4 T cell count
Primary
Objective:
To
determine the safety and identify a
biologically active dose of CYT107 (3
doses, 1 does per week for 3 weeks) in
chronically HIV infected patients
receiving antiretroviral therapy, with
CD4 T lymphocyte counts between
101-400 cells/mm and plasma HIV RNA
<50 copies/mL for at least 6 months.
Major
Requirements to Enter Study:
Treatment:
Subcutaneous injections of Interleukin-7 CYT107 at rate of 1 injection
per week for 3 weeks.
Dose escalation study with 3 dose
levels cohorts: Cohort A: 10 µg/kg/week
Cohort B: 20 µg/kg/week
Cohort C: 30 µg/kg/week.
Steering committee review of
safety data, pharmacokinetics and
immunogenicity prior to enrollment of
subsequent cohorts.
Duration
of Study:
28
days on study with 3 month follow up.
Up to 12 months post-study
follow-up.
Compensation:
Compensation
is paid to participants.
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A5232:
Optimizing Vaccine Responsiveness in
HIV-1 and HCV Infections by Identifying
Determinants of Responsiveness: A Pilot
Study
Brief
Description:
A5232
is a 24-week research study, which is
enrolling people who have hepatitis C,
people who are HIV-positive, and people
who are co-infected with HIV and hepatitis
C. Participants
will be given two types of vaccines:
diphtheria/tetanus toxoid and hepatitis A
and B.
The study will look at the
immunological effects of the vaccinations.
Purpose of this
Clinical Trial: A5232
is a pilot study to look at the extent of
immune defects in people who have
hepatitis C, HIV, and both.
This will be done by immunizing
people with antibodies to both tetanus
toxoid and hepatitis A and B, and
evaluating their immune systems’
responses.
Major
Requirements to Enter Study:
- Men and Women
ages 18-65 who
have not had prior exposure to the
hepatitis A or B vaccine;
- Hepatitis A
antibody negative; hepatitis B surface
antigen and antibody negative.
- The study will
enroll three groups (called
“Arms”) of people:
- Arm
A:
(currently not enrolling at
Case/UHC)
People who have chronic hepatitis C
infection (and do not have HIV
infection):
- Defined as
PCR positive without previous
Hepatitis C therapy and without
the presence of Child’s B or C
cirrhosis;
- Arm B:
People who have HIV infection (and
do not have hepatitis C infection)
- Who have
not taken more than 7 days of
antiretroviral therapy (HAART);
- CD4 count
of 300 or more;
- No prior or
current opportunistic infections;
- With no
indication of need for
antiretroviral therapy
- Arm C:
People who have both
hepatitis C and HIV infection, and
meet the requirements of both Arm A
and B
Treatment:
All
participants will receive a vaccination
for diphtheria/tetanus toxoid, and a
combined hepatitis A and B vaccine.
Length
of Trial:
24 weeks
Compensation:
Trial participants receive
compensation.
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A5240:
A study for HIV-positive women to
determine
the
safety and effectiveness of the HPV
vaccine, Gardasil.
Brief
Description:
Human papillomavirus (HPV) is the
most common sexually transmitted disease
in the
United States
and worldwide.
There are over 90 types of HPV
that infect humans.
Some of these types infect the
genital and anal areas where the
infection causes genital and anal warts.
It also causes cancer of the
cervix (the opening of the uterus) in
females.
HPV infection may be more severe
and harder to treat in people infected
with HIV.
The FDA has approved an HPV
vaccine (called Gardasil), and it is
directed against 4 types of HPV which
are the most common causes of genital
warts and cervical cancer.
This study is the first of its
kind to test the HPV vaccine in females
infected with HIV.
Purpose
of this Study:
This
study will see if the HPV vaccine, when
given in 3 separate doses, is safe and
tolerable in females infected with HIV.
This will be done by asking how
you feel and if you had any reactions
after each dose of the vaccine.
The study will also check if the
HPV vaccine can help the body make
substances in response to the
vaccination to help fight off disease
caused by HPV.
Requirements
to Enter Study:
·
HIV-positive
females, ages 18-45 years old.
·
Any
T-cell count and any viral load is
acceptable.
·
If
you are taking antiretroviral drugs, you
must be on the same combination of
medicines for at least 12 weeks before
the study entry visit.
You do not need to be on
antiretroviral drugs to be eligible for
this study.
·
No
cervical cancer, very abnormal Pap
smear, or genital warts within 180 days.
·
No
prior vaccinations for HPV.
·
Cannot
take any of the disallowed medications.
Your study nurse will discuss
these with you.
Treatment:
Study
treatment is defined as quadrivalent HPV
(types 6, 11, 16, 18) recombinant
vaccine, Gardasil, and will be provided
to you by the study. Quadrivalent
means that the vaccine is directed at
four types of HPV.
If you are currently taking
antiretroviral drugs, you should
continue taking them unless your doctor
tells you otherwise.
Your antiretroviral drugs will
not be provided to you by the study.
You must get them through your
primary care provider.
Duration
of Study:
This study will last about one and a
half years.
Compensation:
You will be provided compensation for participation in this
study.
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A5176:
A Clinical Trial of a Vaccine for HIV+
People
Purpose
of the Clinical Trial:
This
Phase I/II* study is being done to find
out whether DermaVir vaccine (LC002) is
safe and tolerable in humans and what
the best dose is for treating HIV
infection in people who are currently on
antiretroviral medications (HAART).
The safety of DermaVir is
currently being studied in persons with
HIV in another study in
Europe
.
*
A Phase I clinical trial is one in which
a study medicine is given to a small
group of people to evaluate its safety.
A Phase II clinical trial is one
in which the study medication is given
to larger groups of people to see if it
works and to further evaluate its
safety.
How
It Works: Study
treatment is DermaVir or DermaVir
placebo. Depending on when you enter in
the study you will be registered to one
of the three groups noted below. In the
group you are registered in you will be
assigned (by chance, like the flip of a
coin) to receive either DermaVir
vaccinations or placebo vaccinations (a
placebo is the same vaccine without an
active component). You have a 75% chance
of actually receiving the DermaVir
vaccine and a 25% chance of receiving
the placebo vaccine:
-
If you enter into group 1 you will
receive low dose vaccinations at weeks
1, 7, and 13 (applied over 2 skin
sites).
-
If you enter into group 2 you will
receive high dose vaccinations at weeks
1, 7, and 13 (applied over 4 skin
sites).
- If you enter into group 3 you will
receive high dose vaccinations at entry
and at weeks, 0, 1, 6, 7, 12, and 13
(applied over 4 skin sites).
This
new vaccine will not be injected into
your body like other vaccines. It will
be applied to your skin (after a special
skin preparation process is completed)
in order to target immune cells (known
as Langerhans cells) located just under
the surface of your skin. These
Langerhans cells must pick up the
vaccine in order to train your body to
fight HIV-1.
Key
Requirements to Enter Study:
-
HIV-positive
people, ages 18-50 years old;
-
HIV
Viral load less than 50 and CD4+ T-cell
count greater than 350;
-
On
a stable HAART without changes or
interruptions (for more than 4
consecutive days) for at least 12 weeks
prior to study entry;
-
No
history of AIDS-defining illnesses,
diabetes, major active skin diseases and
chronic autoimmune or bleeding disorders
Duration
of Study:
61
weeks
Compensation
Provided to Participants.
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AIDS 257:
A study to assess the role of mitochondria in
lipoatrophy
Purpose of
Study: This study will evaluate the role of
mitochondria in lipoatrophy w hich is the loss of fat
from specific areas of the body, including the face,
legs and buttocks.
Major
Requirements to Enter the Study: 18 years old or older; either naive and about to
start HAART (anti-HIV medicines) or already taking HAART
and on stable regimen of ZDV or d4T with lipoatrophy.
Brief
Description: Group 1: ARV naive patients ready
to start 1st antiretroviral therapy. ARV
must include d4T, ZDV, or ddI and a
non-nucleoside or Atazanavir (boosted or
not).
Group 2: ARV-experienced
patients, with lipoatrophy, randomized
to 2 Arms:
Arm 1) patients will continue
current regimen with uridine (Nucleomaxx)
added;
Arm 2) patients will have d4T or
ZDV changed to Tenofovir.
Study will include 3 fat biopsies by
plastic surgeon under local anesthetic. Only
Nucleomaxx for Arm 1 will be provided.
Compensation for all visits and each biopsy.
Length
of Trial: 48 weeks
Compensation: Compensation provided.
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