AIDS Clinical Trials Unit, Beth Israel Medical Center, NY

Clinical Trials

Trial Participants

Trials at a Glance: Currently Enrolling HIV/AIDS Clinical Trials

Email this page

This section of the Web site describes the clinical trials currently open to enrollment at the Beth Israel AIDS Clinical Trials Unit (ACTU) in New York. New clinical trials are added frequently, so please check this listing often or call the ACTU now at 800.483.7339 to get the most up to date trial information.

For full details about each trial, click the trial code.

ID Code

Description

Eligibility

No Prior Treatment

No available trials at this time. Please check back periodically.  

Prior HIV Treatment/ Undetectable Viral Load

No available trials at this time. Please check back periodically.  

Prior HIV Treatment/Detectable Viral Load

AMICI - ML20837

 The purpose of this study is to evaluate the effectiveness of Fuzeon (enfuvirtide) with raltegravir, an intergrase inhibitor, in people infected with HIV-1 who have already been treated with medicines from three other HIV drug classes. The study will also investigate whether Fuzeon (which is given as an injection under the skin) 180 mg once daily is as effective as Fuzeon 90 mg twice daily.
  • Have received treatment for your HIV infection
  • Have a viral load higher than 1,000 copies
  • Be able to self-inject the study drug twice a day, or have a reliable care giver who is willing, able and available to assist you with this for the duration of the study

HRG2

HRG2 is a randomized, controlled, open-label, multi-dose trial to determine the efficacy, safety, immunogenicity, and pharmacokinetic profile of PEHRG214 in HIV-infected patients, treated three times weekly for up to 16 weeks.

All patients receive optimized standard of care highly active antiretroviral therapy. The primary objective of the study is to determine the effect of PEHRG214 in decreasing the viral load (>=1.0 log10), as compared to a Control group.

The total sample size is 58-62 patients from approximately 8-10 participating study centers. The first 4-8 patients are enrolled in the non-randomized "pilot arm" and 54 subsequent patients are randomized (2:1 within center) to Treatment or Control group.

 Inclusion Criteria:
  • 18 years of age or older, male or female
  • Serological documentation of HIV infection at any time prior to study entry.
  • CD4 cells count of less than 220 cells/mm3 within 35 days of study drug administration.
  • HIV viral load at least 10 times greater than the site laboratory's lower limit of detection within 35 days of study drug administration.
  • The patient must be taking an optimized background regimen (OBR) of antiretroviral agents.
  • OBR has been stable for at least 4 weeks prior to Screening and is expected to remain stable for the duration of the trial.
Exclusion Criteria:
  • Active opportunistic infection which is progressive, or imminently disabling or life-threatening.
  • Cytotoxic chemotherapy, interferon treatment, or radiation therapy within the preceding 3 weeks (patients who have received intralesional chemotherapy will not be excluded, however).
  • Any investigational drugs within 30 days or any investigational biologic agents within 6 weeks. Expanded access drugs are allowed provided these drugs are not excluded elsewhere in the protocol.
  • Patients who have received an HIV vaccine.
  • Known hypersensitivity to animal proteins, including red meats, milk, or milk products, or previous treatment with a caprine antibody and HAGAR (Human anti-goat antibody response) or the presence of HAGAR at screening.
  • Chronic treatment with immunosuppressant drugs, including corticosteroids, except for the treatment of adrenal insufficiency. Topical steroids are permitted.

 

Protocol P04889

 Vicriviroc (vye-kri-VYE-rock) is an investigational drug that belongs to a new class of drugs, called CCR5 receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells that fight infection). Previous smaller studies in HIV treatment-experienced patients, have shown that vicriviroc is safe and effective. The purpose of this study is to confirm the previous findings in a larger phase 3 study over a 48-week period, and show that when taken in combination with other appropriate HIV drugs, vicriviroc can decrease the level of HIV (viral load) in the blood and that it is well tolerated. Inclusion Criteria:
  • 8 years of age or older, male or femaleSubject must be infected with HIV-1 virus.
  • Subject must have documented plasma HIV-1 RNA >1000 copies/mL within 60 days of Visit 1/Day 1 (randomization) and must be either:
    • on a stable regimen of 3 or more antiretroviral (ART) for at least 4 weeks prior to the screening visit OR
    • on no ART agents for at least 4 weeks prior to the screening visit.
  • Subject must be ART experienced and have documented resistance to at least 2 of the following 3 drug classes: nucleoside reverse transcriptase inhibitor (NRTI); non-nucleoside reverse transcriptase inhibitor (NNRTI); or protease inhibitor (PI) OR
  • Subject must have ART class experience for at least 6 months with at least two of the following: one NRTI; one NNRTI; two PIs (excluding low-dose ritonavir).
Exclusion Criteria:
  • Subjects with detectable CXCR4-tropic or dual/mixed CCR5/CXCR4-tropic HIV isolates at Screening.
  • Subjects with prior history of malignancy (with exceptions of cutaneous Kaposi's sarcoma without visceral or mucosal involvement that resolved with HAART but without systemic anti-cancer treatment, and basal-cell carcinoma of skin); or prior receipt of cytoxic cancer chemotherapy that may increase the risk of malignancy.
  • Subjects with seizure disorder requiring anti-seizure therapy or with any condition that, is likely to increase risk of seizure (CNS malignancy or toxoplasmosis).

Protocol 1182.98

 Safety, efficacy and Pharmacokinetics of tipRanavir boosted with low-dose ritonavir (TPV/r) IN a racially and Gender diverse treatment experienced population with a pilot evaluation of therapeutic drug monitoring. (the SPRING study)

 
  • Must have taken at least 1 drug from each of the 3 classes for more than 3 months
  • Must have developed resistance to more than one protease inhibitor, as shown on the resistance test drawn at the screening visit
  • T-cell count of more than 50
  • HIV viral load of more than 1,000 copies at screening
  • You can not have used tipranavir at any time in the past, or have results of a genotypic resistance test showing that you are resistant to tipranavir.
Experimental HIV drugs obtained through expanded access programs (maraviroc and MK-0518) are permitted to be used during the study.

Complications of HIV or HIV Treatment

BIPI-1100.1452

 A Case-Control Toxicogenomics Study to Identify Unique Genetic Polymorphisms in Patients who have Experienced Symptomatic Hepatotoxicity or Severe Cutaneous Toxicity within the First 8 weeks of Nevirapine Therapy

Inclusion for Cases

  1. Male or female patients >=18 years of age with HIV-1 infection
  2. Experienced one or more of the following adverse reactions within the first 8 weeks of starting nevirapine therapy:
-Grade 3 or 4 LFT elevation (ALT or AST > 5X ULN) and any symptom consistent with clinical hepatitis (see Appendix 10.1) Acute liver failure secondary to nevirapine therapy* Functional group III or IV rash
- Acute liver failure is defined as serious liver injury usually requiring hospitalization that may lead to death or liver transplantation.

Exclusion for Cases

  1. Patients with any hepatotoxicity or rash event which in the investigators judgement is not related to nevirapine use (ex. hepatotoxicity due to alcohol or other medicinal use or rash due to other medicinal use).
  2. Patients who began abacavir or TMP-SMX (trimethoprim/sulfamethoxazole) therapy 2 weeks or less prior to or up to 8 weeks after initiating nevirapine therapy.
  3. Patients with AST or ALT elevations > 5 times the ULN (>= Grade 3) just prior to the initiation of nevirapine therapy.

Inclusion for Control

  1. Have been exposed to nevirapine therapy for at least 18 weeks and who do not meet any of the case inclusion criteria

Exclusion for Controls

  1. Patients who discontinued nevirapine before completing 18 weeks of dosing with 200 mg/day for 2 weeks followed by 400 mg/day thereafter.
  2. Patients who developed functional group I, IIa or IIb rash within 18 weeks of starting nevirapine therapy, or any dermatologic condition that could plausibly be attributed to nevirapine.
  3. Patients with ALT or AST elevations >2.5 X ULN (>Grade 1) within 18 weeks of starting nevirapine therapy.
  4. Any hepatobiliary adverse event that could possibly be attributed to nevirapine.
  5. Patients who develop any systemic reaction attributable to nevirapine use during the first 18 weeks of nevirapine treatment such as flu-like symptoms, arthralgia, myalgia, or conjunctivitis.

Exclusion for Cases and Controls

  1. Patients who have participated in the 2NN-Long-term Follow-up study (1100.1454)
  2. Patients with CD4 count <150 cells/mm3 prior to the initiation of nevirapine therapy (last available result measured <6 months prior to the initiation of nevirapine therapy).
  3. Evidence of acute co-infection with viral hepatitis.
  4. Patients taking prednisone, prednisolone, or immuno-modulatory medication within the first 8 weeks of nevirapine therapy.
  5. Patients who are unwilling to provide blood samples for DNA testing.
  6. Patients without available liver function tests # 6 months prior to initiating nevirapine therapy.
  7. Patients who did not sign informed consent and or authorization to release protected health information per local requirements.

 

Trials for Women

No available trials at this time. Please check back periodically.  

 

Call toll free: 800.483.7339

5

Clinical trials update