This section
of the Web site describes the clinical trials currently open to enrollment
at the Beth Israel Infectious Diseases/AIDS Clinical Trials Unit (IDACTU) in New York. New
clinical trials are added frequently, so 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
|
GS-US-236-0103 |
OPEN TO ENROLLMENT: Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/ Emtricitabine/ Tenofovir Disoproxil Fumarate/GS-9350 vs. ATV/R + TDF/FTC |
Inclusion Criteria:
- Plasma HIV-1 RNA levels greater than or equal to greater than or equal to 5,000 copies/mL
- No prior use of any approved or investigational antiretroviral drug for any length of time
- Age ≥ 18 years
Exclusion Criteria:
- New AIDS defining condition diagnosed within the 30 days prior to screening
- Receiving drug treatment for Hepatitis C, or anticipated to receive treatment for Hepatitis C
- 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
- Active, serious infections (other than HIV 1 infection) requiring
|
GS-US-216-0114 |
OPEN TO ENROLLMENT. Phase 3. To evaluate the safety and efficacy of GS-9350-boosted Atatzanavir Versus Ritonavir-boosted Atazanavir each administered with Emtricitabine/Tenofovir |
Inclusion Criteria:
- Plasma HIV-1 RNA levels greater than or equal to greater than or equal to 5,000 copies/mL
- No prior use of any approved or investigational antiretroviral drug for any length of time
- >Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drug
- Age ≥ 18 years
Exclusion Criteria:
- >New AIDS defining condition diagnosed within the 30 days prior to screening
- Receiving drug treatment for Hepatitis C, or anticipated to receive treatment for Hepatitis C
- 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
- Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline
|
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 |
Inclusion Criteria
- HIV RNA > 1,000 copies/ml
- CD4 > 100
- Trofile R5 Positive
Exclusion Criteria
- Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
- Acute illness or Acute HIV-related OI
- Renal Insuffiency
|
Tibotec TMC278-TIDP6-C209 |
NO LONGER RECRUITING.Phase 3 Double blind trial of TMC278 vs EFV in combination with a fixed background regimen in Naïve subjects
Study Arms
Blinded TMC-278 vs Efavirenz with background Truvada (FTC + TDF) |
- HIV positive
- HIV-1 RNA >5,000 copies/ML
- Antiretroviral naïve
- Must Not Have Documented resistance to NNRTI’s
|
Prior HIV Treatment/ Undetectable
Viral Load
|
|
No available trials at this time. Please check back periodically. |
|
Prior HIV Treatment/Detectable
Viral Load
|
Gilead GS-0144
|
NO LONGER RECRUITING. Phase 3 Double-blind Study of the Safety and Efficacy of Ritonavir-boosted Elvitegravir vs. Raltegravir in Antiretroviral-Experienced Adults
Study Arms
Ritonavir-boosted PI + Elvitegravir + Background regimen vs. Ritonavir-boosted PI + Raltegravir + Background regimen |
- HIV Plasma RNA >1000
- Stable antiretroviral regimen for at least 30 days prior to screening
- No prior treatment with any integrase inhibitor
- Fully active boosted PI regimen on genotype
|
Pfizer A4001067 |
OPEN TO ENROLLMENT.An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-Experienced HIV-1 Infected Patients (POEM)
|
- Ages Eligible for Study: 18 Years and older
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No
- Sampling Method: Non-Probability
- Sample
Study Population
Treatment experienced, HIV-1 infected patients in routine clinical practice.
-
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
|
ANTIBIOTIC STUDIES |
|
No available trials at this time. Please check back periodically. |
|
OTHER STUDIES
|
Sanofi Aventis H-030-011 |
Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection
Study Arms • Placebo Vaccine • Low dose: Experimental vaccine / adjuvant • High dose 1: Experimental vaccine / adjuvant • High dose 2: Experimental vaccine without adjuvant |
Inclusion Criteria
- HIV Negative
- Positive C. diff stool infection ≤ 12 days
- WBC ≤20,000 /µL and stable creatinine levels
Exclusion Criteria
- Current treatment for reoccurrence of CDI
- Subjects who are significantly immunocompromised or immunodeficient due to medications or disease
|
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
|
PHS 398/2590 |
OPEN TO ENROLLMENT. This study will produce the first information about the global serologic antibody response to Pneumocystis using a standard set of antigens; distinguish epitopes that are associated with recovery from those that are not; and provide new information about the responses to Pneumocystis in the normal host. Information gained from this grant will enhance the understanding of the immunology and epidemiology of Pneumocystis infection in humans, lead to a simple serologic test, and stimulate new approaches to the treatment and prevention of PcP.
|
Inclusion criteria:
- Age ≥ 18 years old
- Documented HIV infection
Exclusion criteria:
- Patients with acute pneumonia, cough, shortness of breath, fevers, or a history of PcP within the past 3 months.
- Subjects who are unable or unwilling to provide informed consent will also be excluded.
|
MV21542 (PROPHESYS 3) |
OPEN TO ENROLLMENT. 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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