| 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 |
|
|
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