Clinical Trials Available
in Connecticut
Updated 04/29/2016
Circle Medical, LLC |
153 East
Avenue, Suite #32
Norwalk, CT 06851 |
Dr. Gary Blick, MD |
ID Number /
Protocol Name: (A4001028,
Maraviroc) A Multicenter, Randomized, Double-Blind,
Placebo-Controlled Trial of a Novel CCR5 Antagonist, UK-427,857 (Maraviroc),
in Combination With Optimized Background Therapy Versus Optimized
Background Therapy Alone for the Treatment of
Antiretroviral-Experienced HIV-1 Infected Subjects |
|
|
Age / Gender
Requirements |
Regimen |
Entrance
Criteria |
Details |
CD4 Count |
Viral Load |
Previous HIV Treatment |
Men or women at
least 16 years of age |
UK-427,857, in
Combination With Optimized Background Therapy Versus Optimized Background
Therapy Alone |
Any |
Greater than or
equal to 5,000 copies/mL |
Documented
genotypic or phenotypic resistance to three of the four antiretroviral drug
classes, OR, Antiretroviral-class experience greater than or equal to 6
months (sequential or cumulative) with at least three of the following: One
nucleoside or nucleotide reverse transcriptase inhibitor, one non-nucleoside
reverse transcriptase inhibitor, two protease inhibitors (excluding low-dose
ritonavir) and/or enfuvirtide |
1) 80% randomized
to Maraviroc. 2) 48 week trial with open-label
continuation until FDA approved.
3) Must have R5-tropic virus when screened for the study.
4) Travel expenses reimbursed, if needed. |
|
ID
Number / Protocol Name: (EPZ104057,
HEAT) A
96-Week, Phase IV, Randomized, Double-Blind, Multicenter Study of the
Safety and Efficacy of
EPZICOM
Versus TRUVADA Administered in Combination With KALETRA in
Antiretroviral-Naive HIV-1 Infected Subjects |
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Age / Gender
Requirements |
Regimen |
Entrance
Criteria |
Details |
CD4 Count |
Viral Load |
Previous HIV Treatment |
18 Years and above,
Genders Eligible for Study: Both |
EPZICOM Versus
TRUVADA Administered in Combination With KALETRA in Antiretroviral-Naive
HIV-1 Infected Subjects |
Any |
Must have a viral
load of at least 1,000 copies/mL. |
Must not have
received previous treatment with any anti-HIV medications. |
1) 96 week study.
2) All antiretroviral medication administered free of charge.
3) Study is also known as HEAT. |
|
ID Number
/ Protocol Name: (HPR20001;
STRIVE)
A Phase IIB, Randomized, Multicenter, Parallel Group Study to Evaluate
the Short-Term Safety, PK and Antiviral Activity of Four Dosing Regimens
of GW640385/Rtv Therapy Compared to Open-Label Current Protease
Inhibitor (PI) Therapy in HIV-1, PI-Experienced Adults for 2 Wks With
Long-Term Evaluation (>48 Wks) of Safety, PK and Antiviral Activity of
Selected GW640385/Rtv Dosing Regimen(s) Vs. a RTV-Boosted, PI Containing
Regimen |
|
Age / Gender
Requirements |
Regimen |
Entrance
Criteria |
Details |
CD4 Count |
Viral Load |
Previous HIV Treatment |
18 Years and above.
Genders Eligible for Study: Both |
4 blinded doses of
GW640385 boosted with rtv for 15 days. Continue until drug is approved.
|
Any |
Greater than or
equal to 1,000 copies/mL |
At least 2 multi-PI
resistant mutations at Screening or within 3 months of Screening.
Must have been receiving the same anti-HIV medicines that
they are on currently for at least 8 weeks prior to Screening. These
anti-HIV medicines will include a single protease inhibitor (PI) in
combination with a low dose of ritonavir (i.e., a ritonavir-boosted PI).
However, the current PI cannot be tipranavir. |
1) This study is
also known as HPR20001; STRIVE. 2) Stipend for 12
hour pharmacokinetic study visit. |
|
ID
Number / Protocol Name: (VICTOR-E1,
P03672)
Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART
Regimen in Experienced Subjects |
|
Age / Gender
Requirements |
Regimen |
Entrance
Criteria |
Details |
CD4 Count |
Viral Load |
Previous HIV Treatment |
18 Years and above,
Genders Eligible for Study: Both |
Randomized,
placebo-controlled, multi-site, parallel-group, double-blind study despite
standard antiretroviral therapy (ART) that the subject has been receiving
continuously for at least 3 months vicriviroc 10 mg QD, vicriviroc 15 mg QD,
or placebo |
N/A |
Must have a viral
load of at least 5,000 copies/mL. |
Greater than or
equal to 1 genotypically documented resistance mutation to a reverse
transcriptase (RT) inhibitor and greater than or equal to 1 primary
resistance mutation to a PI
|
1) R5 tropism
2) Open-label rollover at the end of 48 weeks |
|
ID
Number / Protocol Name: (VICTOR-E2,
P04285)
Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART
Regimen in Experienced Subjects |
|
Age / Gender
Requirements |
Regimen |
Entrance
Criteria |
Details |
CD4 Count |
Viral Load |
Previous HIV Treatment |
18 Years and above,
Genders Eligible for Study: Both |
Randomized,
placebo-controlled, multi-site, parallel-group, double-blind study despite
standard antiretroviral therapy (ART) that the subject has been receiving
continuously for at least 3 months vicriviroc 10 mg QD, vicriviroc 15 mg QD,
or placebo. |
N/A |
Must have a viral
load of at least 5,000 copies/mL. |
Greater than or
equal to 1 genotypically documented resistance mutation to a reverse
transcriptase (RT) inhibitor and greater than or equal to 1 primary
resistance mutation to a PI |
1) R5/X4 Mixed
tropic 2) Open-label rollover at the end of 48 weeks |
|
|
Project BRIGHT |
New Haven,
CT |
For more information contact: David Fiellin, M.D.
(203) 688-2984
david.fiellin@yale.edu |
Study ID |
Regimen |
Entrance
Criteria |
Details |
CD4+ |
Viral Load |
Previous HIV Treatment |
NAÏVE OR EXPERIENCED,
18 years of age or older |
Buprenorphine
|
Comparison of
buprenorphine and counseling treatments for opioid (heroin or prescription
narcotic) dependent HIV seropositive patients |
All |
All |
NA |
Assignment to
either: Buprenorphine and physician management or buprenorphine, physician
management, and drug and adherence counseling
Patients should be 18 years of age or and older, HIV
seropositive, meet criteria for opioid addiction, not pregnant and willing
to use contraception while in study.
Patients who have a life-threatening medical or psychiatric problems are not
eligible.
Counseling may be provided free of charge and free medication for those
who qualify. |
To participate in the BRIGHT
study call 203-314-3674 or
203-781-4650, extension 276 |
NEW ENGLAND ProACT YALE
UNIVERSITY AIDS CLINICAL TRIALS PROGRAMOpen STUDIES AS OF July 17, 2003
New England Programs for AIDS Clinical
Trials (ProACT) |
New Haven,
CT |
For general
information about PROACT contact: Laurie Andrews, RN, MPH
(203) 785-3557
Laurie.Andrews@yale.edu |
Study ID |
Regimen |
Entrance Criteria |
Details |
CD4+ |
Viral Load |
Previous HIV Treatment |
NAÏVE OR EXPERIENCED |
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If you know of another research site and/or corrections
to the current listings contact us
The law
requires everyone who is participating in a drug study to be provided with
information about the study and to give informed consent. In the informed
consent you will be told the purpose of the study, the drugs that will be
used, the possible risks and benefits of the drugs, the number of study
visits and the tests to be done at each visit.
Be
sure to understand all the benefits and risks of participating in a research
study before signing your informed consent.
When you sign the
consent form, that means you fully understand what the study is, how it
works, how long it will last, what you need to do, any potential risks and
benefits of participation.
In addition, each
research study is monitored closely be an institutional review board (IRB),
which reviews all aspects of the conduct of the study, including procedures,
risks and benefits of the study and reviews ongoing findings to insure the
protection of all study participants. By law, no clinical research study
may operate without the oversight of an IRB, which acts on behalf of the
Food and Drug Administration
Clinical trials are
free of charge. Each study has its own eligibility criteria and
requirements. Some trials, for example, want people who haven’t taken HIV
drugs before, and others want people who have been on them for a while and
some studies will enroll either those who have taken medications before and
those who have not.
There is no
guarantee that the medication being tested or the treatment strategy being
used is as effective as what you would receive without the study.
There may be a chance that the medications used in the study will have
harmful side effects.
There may be a chance that the medications used in the study will not work
well together.
It is likely that you will have additional health care visits.
What are the
Benefits to Participating in a Clinical Trial?
Sometimes you may receive a treatment before it is widely available
Sometimes medications are provided at no cost
Sometimes laboratory tests are provided at no cost
You will usually receive additional medical attention at no cost.
Sometimes you will receive a stipend for your time.
When
enrolling for a clinical trial, you are not only getting access to the
latest HIV treatments and care, but you are also helping to advance our
knowledge about how HIV works and better HIV management.
It is
important, therefore, to take this responsibility seriously. |
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