Center for AIDS Research (CFAR)
Clinical Trials
DFCI-BIDMC-CH clinical trials
HIV Infection in Children: Fortovase, Nelfinavir, Ritonavir, Hydroxyurea, Nevirapine, d4T, ddI, 3TC
Title: Pediatric ACTG P1007: Multi-Drug Antiretroviral Therapy For Heavily Pretreated Pediatric AIDS Patients: A Phase I Proof of Concept Trial Purpose: To see if eight HIV drugs, some of them given at higher than normally used doses, is safe and tolerated by children with advanced HIV infection who have failed to respond to other treatments. Children's Hospital of Boston - Catherine Kneut, Boston, MA (617) 355-7879
HIV Infection in Children: HAART and Immune Function
Title: Pediatric ACTG P1006: The Effects of Highly Active Antiretroviral Therapy (HAART) on the Recovery of Immune Function in HIV-Infected Children Purpose: To see how many immune system cells return, how quickly those immune cells that are able to fight both new and old infections return, and the amount of HIV in the blood of children who are taking Highly Active Antiretroviral Therapy (HAART). Children's Hospital of Boston - Catherine Kneut, Boston, MA (617) 355-7879
HIV Infection in Children: Varicella-Zoster Virus Vaccine
Title: Pediatric ACTG 391: Use of Live-Attenuated Varicella-Zoster Virus (VZV) Vaccine To Boost Immunity to VZV in HIV-Infected Children Previously Infected with Varicella Purpose: To see if Varicella Virus Vaccine (Varivax) is safe and if it can help to prevent shingles in HIV-infected children who have already had chicken pox. Children's Hospital of Boston - Catherine Kneut, Boston, MA (617) 355-7879
HIV Infection in Women: Abacavir, Combivir, Nelfinavir, d4T, 3TC
Title: ESS40002: A 96-Week, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40mg BID) + Lamivudine (150mg BID) + Nelfinavir (1250mg BID) versus Abacavir (300mg BID) + Combivir (3TC 150mg/ZDV 300mg BID) versus Combivir (3TC 150mg/ZDV 300mg BID) + Nelfinavir (1250mg BID) in HIV-1 Infected Female Subjects Purpose: To evaluate fat redistribution changes in female patients treated with a triple NRTI combination compared to two separate three-drug combinations each containing two NRTIs and one protease inhibitor. Beth Israel Deaconess Medical Center - Helen Fitch, RN, Boston, MA (617) 632-0785
HIV Infection: Indinavir, Ritonavir (2)
Title: Merck 088-00: A Multicenter, Open-Label, 24-Week Study to Evaluate the Safety and Activity of Indinavir Sulfate 800 mg b.i.d. in Combination With Ritonavir 200 mg b.i.d and Two NRTIs in HIV-1 Infected Patients Who Failed PI Therapy Purpose: To see if the combination of indinavir and ritonavir is capable of producing higher drug levels in the blood and in slowing the development of drug-resistant HIV virus for HIV-infected patients who have failed protease inhibitor therapy. Beth Israel Deaconess Medical Center - Lynn Dumas, RN, Boston, MA (617) 632-0781
HIV Infection: Interleukin-2, HAART
Title: CS-MM-9901: A Bridging Dose-Escalation Study of the Safety, Pharmacokinetic Properties, and Immunologic Effect of Subcutaneous L2-7001 (Recombinant Human Interleukin-2) in Patients Infected with HIV with CD4+ T-Cell Counts of 300-500 cells/mm3 and Viral Burden Under 10,000 copies/mL on Active Antiretroviral Therapy (ART) Purpose: To see which of three different doses of L2-7001 (a new formulation of interleukin-2) is best when combined with antiretroviral therapy and compared to proleukin (a different form of interleukin-2). Fenway Community Health Center - Ronn Bill, Boston, MA (617) 927-6035
HIV Infection: Ritonavir, Indinavir (2)
Title: M99-047: The Norvir/Indinavir Combination Evaluation Study: A Randomized, Controlled, Open-Label Comparison of Continuing Indinavir Q8H vs. Switching to Norvir/Indinavir 400 mg/400 mg/BID (The NICE Study) Purpose: To study the medication-taking habits and preference of HIV-infected patients taking indinavir and ritonavir twice a day compared to taking indinavir three times a day. To see if these two treatments are safe, well-tolerated and effective in maintaining undetectable HIV viral load when combined with two NRTIs. Fenway Community Health Center - Ronn Bill, Boston, MA (617) 927-6035
KS Treatment: IM862
Title: AMC013: A Phase III, Randomized, Placebo-Controlled and Double-Blind Study of IM862 for Patients With Mucocutaneous AIDS-Associated Kaposi's Sarcoma Purpose: To compare complete and partial responses to KS lesions between IM862 and placebo. To see if IM862 has any effect on HIV. Beth Israel Deaconess Medical Center - Oncology - Jo Ann Proper, RN, Boston, MA (617) 667-9925
KS Treatment: Paclitaxel, DOXIL
Title: AMC009: Phase III Trial of Paclitaxel Versus Liposomal Doxorubicin for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma Purpose: To compare paclitaxel and liposomal doxorubicin (DOXIL) for safety, tolerability and response rate to advanced KS lesions. To see if each of these two treatments has any effect on the HIV virus. Beth Israel Deaconess Medical Center - Oncology - Jo Ann Proper, RN, Boston, MA (617) 667-9925
Non-Hodgkin's Lymphoma Treatment: Ifosfamide/Etoposide, Interleukin-2, Interleukin-12
Title: AMC008: A Randomized Pre-Phase II Trial of Interleukin-2, Interleukin-12, or No Additional Therapy Following Response to Ifosfamide/Etoposide Chemotherapy for Refractory HIV-Associated Non-Hodgkin's Lymphoma Purpose: To see if interleukin-2 and interleukin-12 are safe and effective as maintenance therapy for non-Hodgkin's lymphoma. Beth Israel Deaconess Medical Center - Oncology - Jo Ann Proper, RN, Boston, MA (617) 667-9925
