From this Trials-at-a-Glance summary page, you can navigate to detailed listings for all clinical trials currently open to enrollment or in progress
at the Beth Israel Infectious Diseases/AIDS Clinical Trials Unit (IDACTU) in New York.
Please check this listing
often or call the Aids Clinical Trials Unit now at: 212.420.4519 or toll free 800.483.7339 to get the most up-to-date trial information.
ID Code |
Description |
Eligibility |
No Prior Treatment Or Prior Treatment and Virologically Detectable |
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NOW OPEN: A Phase 3b, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir Plus Two Fully Active Nucleoside Reverse Transcriptase Inhibitors in HIV 1 Infected, Antiretroviral Treatment-NaÔve and -Experienced Adults With No Darunavir Resistance-associated Mutations |
Inclusion Criteria:
- Treatment Naive: No prior use of any approved or investigational antiretroviral drug for any length of time OR
- Treatment Experienced: Stable antiretroviral regimen for at least 12 weeks prior to screening
- Plasma HIV 1 RNA levels greater than or equal to 1000 copies/mL at screening
- Screening genotype report shows full sensitivity to two nucleoside analogue reverse transcriptase inhibitors (NRTIs) and no darunavir resistance associated mutations
Exclusion Criteria:
- Previous or current use of darunavir
- A new AIDS-defining condition diagnosed within the 30 days prior to screening.
- Subjects receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study.
- A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma .
- Participation in any other clinical trial
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No Prior Treatment
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GSK ING114467 |
NO LONGER RECRUITING: SINGLE A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects >> Details |
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Pfizer A4001095 |
COMING SOON: A Multicenter, Randomized, Double-blind, Comparative Trial of Marviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir + Darunavir/Ritonavir For The Treatment Of Antiretroviral – Naïve HIV – Infected Patients With CCR5 – Tropic HIV-1 |
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Pfizer A4001078 |
NO LONGER RECRUITING. No Prior Treatment. Pilot study of Maraviroc + ATV/R vs. ATV/r + Truvada in HIV ARV Naïve, R5 Positive Patients |
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Prior HIV Treatment/ Undetectable
Viral Load
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GS-US-264-0106 |
NO LONGER RECRUITING. A Phase 3 Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically Suppressed, HIV 1 Infected Patients |
Inclusion Criteria:
- Currently receiving antiretroviral therapy with a ritonavir-boosted PI and two NRTIs continuously for greater than or equal to 6 months preceding the screening visit
- Have plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels for greater than or equal to 6 months prior to the screening visit and have HIV RNA less than 50 copies/mL at the screening visit
- Be on their first or second antiretroviral drug regimen; if on their second regimen, must not have had HIV 1 RNA >50 copies/mL at the time of the change in antiretroviral drugs, nor ever experienced two consecutive HIV RNA >50 copies/mL after first achieving HIV RNA 50 copies/mL
- Have a genotype prior to starting initial antiretroviral therapy and have no known resistance to any of the study agents
Exclusion Criteria:
- A new AIDS defining condition diagnosed within the 30 days prior to screening except CD4 cell count and/or percentage criteria
- Current alcohol or substance abuse
- A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
|
Prior HIV Treatment/Detectable
Viral Load
|
Pfizer A4001067 |
NOW OPEN.An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-Experienced HIV-1 Infected Patients (POEM)
|
Inclusion Criteria
- Treatment experienced,
- HIV-1 infected patients
- 18 years or older
- Receive an approved assay for determination of HIV-1 tropism
Exclusion Criteria:
- Pregnant or lactating
- Using CCR5 inhibitor other than maraviroc
|
GSK SAILING ING111762 |
NOW OPEN. A Phase III Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered with an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-NaÔve, Antiretroviral Therapy-Experienced Adults |
Inclusion Criteria:
- Antiretroviral therapy (ART)-experienced
- HIV-1 infection as documented by HIV-1 RNA >400 copies/mL
- Have documented resistance (via Screening resistance test) to two or more different classes of antiretroviral agents.
- Integrase inhibitor (INI)-naÔve, defined as no prior exposure to any INI (e.g. RAL, elvitegravir, or GSK1349572).
Exclusion Criteria:
- Screening resistance test result indicates no fully active antiviral agents are available for design of the background regimen.
- Any evidence of an active AIDS-defining condition (except cutaneous Kaposi's sarcoma not requiring systemic therapy or CD4+ less than 200c/mm3).
- Anticipated need for hepatitis C therapy during the study.
- History of malignancy within the past 5 years or ongoing malignancy.
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ANTIBIOTIC STUDIES |
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No available trials at this time. Please check back periodically. |
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OTHER STUDIES
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Hoffman La Roche NV 25118 |
NOW OPEN: Randomized, Single Blinded, Parallel Study of the Safety of the 100mg and 200mg Oseltamivir (Tamiflu) Administered Intravenously for the Treatment of InfluenzaStudy Arms: • Oseltamivir 100mg vs. Oseltamivir 200mg |
Inclusion Criteria
- HIV Negative
- Diagnosis of influenza
- >96 hours between the onset of influenza-like illness and first dose of study drug
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MV21542 (PROPHESYS 3) |
NOW OPEN. A Prospective Observational Study On Predictors of Early on-treatment Response and Sustained Virological Response in a cohort of treatment naïve HCV-infected patients treated with pegylated interferons |
Inclusion/Exclusion criteria:
- HIV and HCV co-infection only
- No history of prior treatment with pegylated interferon and/or ribavirin
- No Co-infection with Hepatitis B
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