..Empowering People with Challenges  

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
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

NAŌVE 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

NAŌVE OR EXPERIENCED

           
 
           
 
           
 

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 havenít 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.

 

 
     

© 2015 The Guardian Health Association, Inc
all rights reserved