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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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A
5257:
A
Research Study for People Who Are Stating Anti-HIV
Medicines for the First Time:
Brief
Description:
This study is for people who are HIV positive but
have never taken anti-HIV medications.
Each person will randomly be selected to go
into one of three groups. Each group will be taking
a different set of HIV medications. All
of the drugs used in this study are approved by the
U.S. Food and Drug Administration (FDA) for treating
HIV/AIDS; however, darunavir and raltegravir are not
currently approved by the FDA for treating people
who have never taken HIV medication before.
Purpose
of this Study: To
learn whether the medication combinations work
equally well in people who have never taken HIV
medications before. It will also look at how easy
the medications are to take and their side effects.
Requirements
to Enter Study:
·
HIV-1
infected people at least 18 years of age
·
Have
not taken HIV medication (there are a few exceptions
that the study staff can discuss with you)
·
No
resistance to the type (class) of medications
provided by the study on a test called a genotype.
·
HIV
viral load (HIV level) currently 1000 or higher
·
Other
requirements which your study nurse will discuss
with you
Study
Drugs: During the study you will
assigned (by chance) to one of the following
treatments:
Arm
A:
Atazanavir 300 mg once daily + ritonavir 100
mg once daily + emtricitabine/tenofovir disoproxil fumarate 200/300 once
daily
Arm
B:
Raltegravir 400 mg twice daily + emtricitabine/tenofovir disoproxil fumarate 200/300 once
daily
Arm
C:
Darunavir 800 mg once daily + ritonavir 100
mg once daily + emtricitabine/tenofovir disoproxil fumarate 200/300 once
daily
All study medications are provided with the
exception of ritonavir which must be obtained
through a primary care physician. You will be
reimbursed for the cost of your
co-payment.
All
of the drugs used in this study are approved by the
U.S. Food and Drug Administration (FDA) for treating
HIV/AIDS; however, darunavir and raltegravir are not
currently approved by the FDA for treating people
who have never taken HIV medication before.
Duration of Study:
About 2 years after the last person starts the
study.
Compensation:
Compensation
is provided for all visits.
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A
5258: A
Research Study About the Immune
System’s response to HIV Infection
Brief
Description:
It
is thought that immune activation in
HIV-positive people is a major cause in
the harming of the immune system.
This research study will look at
whether taking a medicine, chloroquine,
will reduce the amount of immune
activation seen in people with
HIV-infection who are not on anti-HIV
medicines (HAART).
Everyone who enrolls in the study
will receive chloroquine at some point
in the study.
Purpose
of this Study: To
learn whether taking chloroquine has a
positive effect on CD8+ and CD4+ cells.
Requirements
to Enter Study:
·
HIV-1
infected people at least 18 years of age
and 65 years old and younger.
·
Have
not taken anti-HIV medications (HAART)
within the last 6 months.
·
Not
likely to start HAART within the next 6
months.
·
CD4+
cell count at least 400
·
HIV
viral load at least 10,000.
·
Cannot
have had AIDS-related opportunistic
infections.
·
Cannot
have used chloroquine or
hydroxychloroquine within 3 months of
beginning the study.
·
Cannot
have had retinal disease, porphyria,
psoriasis, cirrhosis, acute hepatitis or
seizure disorder within 6 months of
beginning the study.
Regimen:
At
the beginning of the study you will be
randomly assigned to one of two groups
or arms.
Neither your doctor, nurse nor you will
know which group you are in.
Arm
A:
For the first 12 weeks, you will
orally take chloroquine once a day.
For the second 12 weeks, you will take a
placebo (sugar pill) once a day.
Arm
B:
For the first 12 weeks, you will
orally take a placebo (sugar pill) once
a day.
For
the second 12 weeks, you will orally
take chloroquine once a day.
Following
the first 24 weeks, you will remain on
the study for another 4 weeks of
observation.
Duration
of Study:
28 weeks.
There are 10 visits during this
study.
Compensation:
Compensation
is provided.
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