HIV/AIDS Clinical Trials Available
in Connecticut

Updated 09/15/2007

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

NAÏVE OR EXPERIENCED

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

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