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HIV Clinical Trials in the Los Angeles Area

NZTA-4008 (New Trial)
Meds Used Epivir, AZT, Sustiva
Tx History Antiretroviral naive
Trial Length 48 weeks
Viral Load >400
T-Cells >100
Comments Study to determine the efficacy of Epivir once a day ion combination with AZT and Sustiva vs. twice a day.
Contact Kai Gu, Pacific Oaks Research, (310) 360-8800
ABT-378 (New Trial)
Meds Used ABT-378
Tx History NNRTI-naive and prior use with only one PI
Trial Length 48 weeks
Viral Load >1,000
T-Cells No requirement
Comments Phase IV study to evaluate ABT-378 in PI-experienced participants
Contact Kai Gu, Pacific Oaks Research, (310) 360-8800
Norvir-Crixivan Intensification
Meds Used Norvir/ Crixivan
Tx History All participants must be on Crixivan, on the same regimen for three months or longer, and Norvir naive
Trial Length 48 weeks
Viral Load Between 50 and 50,000
T-Cells No requirement
Comments Norvir/Crixivan intensification therapy for HIV-infected individuals. Crixivan will be taken twice daily at elevated doses along with a lower dose of Norvir.
Contact Jacqui Pitt, R.N., Cedars Sinai, (310) 855-3755; Ruth Pinter, R.N., Beer Medical Group, (323) 937-5151
Resistance
Phenotypic Testing
Meds Used Phenotype test
Tx History Must have at least six months of prior antiviral therapy
Trial Length One year
Viral Load >400
T-Cells No requirement
Comments Randomized study to determine if use of a phenotype resistance assay will improve ability to choose antiretroviral regimens. Participants must have failed one or two PI-containing regimens
Contact Sadia, Harbor UCLA, (310) 222-5291; Christine MacNaughton, UCLA, (310) 206-6414
Viracept-Combivir + Remune
Meds Used Viracept, Combivir, Remune
Tx History Antiretroviral naive
Trial Length 48 weeks
Viral Load >10,000
T-Cells >250
Comments Randomized, adjuvant-controlled study to compare the virologic and immunologic effects of HAART plus Remune vs. HAART plus Incomplete Freund's adjuvant
Contact Corie Castro, AIDS Research Alliance, (310) 358-2429
Zerit Extended Release
Meds Used Zerit, approved antiretrovirals
Tx History NRTI-naive
Trial Length 48 weeks
Viral Load >5,000
T-Cells >100
Comments Evaluation of the safety and antiviral activity of Zerit extended release vs. immediate release formulations, each as part of potent antiretroviral combination therapy
Contact Corie Castro, AIDS Research Alliance, (310) 358-2429
ACTG 383/Hepatitis C
Meds Used This is an observational study, approved antiretrovirals from a co-enrollment of another study
Tx History Must have a diagnosis of Hepatitis C and HIV, less than 2 weeks of antiretroviral therapy
Trial Length 48 weeks
Viral Load >2,500
T-Cells No requirement
Comments To determine the dynamics of Hepatitis C virus levels in people with HIV infection whose viral load is reduced to less than 500 copies after 16 weeks of HAART. Participants must be co-enrolled in either ACTG 388 or 384.
Contact Sally or Mario, Harbor-UCLA, (310) 222-3848; Connie Funk, R.N., USC, (323) 343-8282
ACTG 371
Meds Used Combivir, Ziagen, Agenerease
Tx History Treatment naive
Trial Length 48 weeks of treatment plus follow up
Viral Load >2,000 within seven days of study entry
T-Cells No requirement
Comments Study to evaluate the safety and efficacy of quadruple combination therapy which consists of Combivir, Ziagen and Agenerase in people with Acute HIV infection and people who have recently seroconverted
Contact Connie Funk, R.N., USC, (323) 343-8282
Metabolic Disorders
Amprenavir
Meds Used Agenerase, Ziagen, Epivir or Zerit
Tx History PI naive
Trial Length 28 week
Viral Load No requirement
T-Cells >100
Comments Study looking at the effect of Agenerase on carbohydrate and lipid metabolism. Participants will receive Agenerase twice a day (BID) plus Ziagen (BID) plus Epivir (BID). If individuals have received Epivir in the past they will receive Zerit (BID)
Contact Hannah Edmondson-Melancon, R.N., USC, (323) 343-8280
Sustiva
Meds Used Sustiva plus your current antiviral therapy
Tx History Must be on PI therapy for at least four months, NNRTI naive, abnormal levels of lipids in the blood or a high waist measurement compared to hip measurement
Trial Length Six months
Viral Load <50
T-Cells No requirement
Comments Study looking at the effect of substituting Sustiva for PI therapy in individuals at increased risk for cardiovascular complications due to HIV-associated metabolic disorders. Participants will be randomized to remain on current therapy or switch to Sustiva
Contact Patsy Lopez, USC, (323) 343-8277
L-756423
Meds Used L-756423, Crixivan, Zerit, Epivir
Tx History Less than two weeks prior therapy with antiretrovirals and no prior treatment with PIs or Epivir
Trial Length 48 weeks or longer
Viral Load >10,000
T-Cells >100
Comments Study to determine the efficacy of L-756423, a new PI. There will be two groups: Group one will receive L-756423 along with Crixivan, Zerit, and Epivir. Group two will receive the same regimen without L-756423
Contact Christine MacNaughton, UCLA, (310) 206-6414
Adefovir
Meds Used Adefovir
Tx History Must be on stable HAART for a minimum of 16 weeks prior to screening and no other serious infections requiring antibiotic/antiviral therapy
Trial Length 48 weeks
Viral Load Between 50 and 400 copies
T-Cells 50 or greater
Comments Study to measure antiviral activity and safety of adefovir as compared to placebo when added to stable highly active antiretroviral treatment (HAART). Participants will receive $20 for each completed visit
Contact Gary Aquino, L.V.N., Pacific Oaks Research, (310) 360-8800
Sustiva Combination Therapy
Meds Used Sustiva
Tx History NNRTI naive
Trial Length 48 weeks
Viral Load Must have two consecutive viral load tests under 50
T-Cells No requirement
Comments Randomized study to compare duration of viral suppression of a continued PI plus two NRTIs regimen vs. a Sustiva substitution regimen and to evaluate the safety and tolerability of these regimens
Contact Kai Gu, R.N., Pacific Oaks Research, (310) 360-8800
BID vs. TID
Meds Used Retrovir, Crixivan, Rescriptor
Tx History Naive to 3TC, NNRTIs, PIs, and limited experience with AZT (no more than one month).
Trial Length 32 weeks (with possible extension to 56 weeks)
Viral Load >20,000
T-Cells >50
Comments Open label study to evaluate the safety and tolerance of investigational combination therapies when taken twice a day versus three times a day. Participants will receive a $20 transportation stipend for every scheduled visit, once enrolled.
Contact Doug Bowden, AHF Research Center, (323)913-3953
ACTG 400
Meds Used Approved anitretrovirals
Tx History Naive to Viramune, Rescriptor or Sustiva is allowed. No prior exposure (less than seven days) to Agenerase, Invirase, Crixivan or Norvir is allowed
Trial Length 48 weeks
Viral Load >1000
T-Cells No requirement
Comments Comparative study of salvage antiretroviral therapies for HIV-infected individuals with evidence of nelfinavir treatment failure as reflected by viral load of more than 1,000
Contact Connie Funk, R.N., USC, (323) 343-8282
ACTG 384
Meds Used Study includes various combinations of Videx, Retrovir, Zerit, Epivir, Sustiva, Viracept
Tx History Must have less than seven days prior therapy with any antiretroviral medications
Trial Length Three years
Viral Load <500
T-Cells No requirement
Comments Randomized double-blind, six-arm study of PIs and/or NNRTIs in combination with NRTIs in initial therapy of HIV infection
Contact Christine MacNaughton, UCLA, (310) 206-6414; Miriam, Harbor-UCLA, (310) 222-3848: Connie Olson, USC, (323) 343-8279
Adefovir Expanded Access
Meds Used Adefovir
Tx History Individuals who have failed combination therapy with commercially available antiretrovirals and have limited treatment options
Trial Length Until FDA approved
Viral Load Must be 30,000 or more (by PCR), or 15,000 or more (by bDNA) within the past two months
T-Cells Must be 50 or less within the past two months
Comments See Tx history
Contact Leanne Onsing, R.N., Lim-Keith Multispecialty Medical Clinics, (323) 964-1440; Marsue Davidson, Kraus Medical Partners, (323) 930-2324 or (800) 860-0700
Immunotherapy
Interleukin-2
Meds Used Interleukin-2
Tx History Stable antiviral therapy of more than three drugs for longer than four months
Trial Length Five years
Viral Load <10,000
T-Cells >50 and <300
Comments Phase III study to evaluate the efficacy of Interleukin-2 (IL-2) in HIV-infected individuals on active antiretroviral therapy with low CD4 counts. Participants will be randomized to receive IL-2 or to a control arm. Compensation provided.
Contact Petra, Harbor, UCLA, (310) 222-3848
Procaine Hydrochloride
Meds Used Procaine Hydrochloride plus Videx and Hydroxyurea
Tx History Participants must have a minimum of eight weeks stable antiretroviral therapy, no active opportunistic infections (OI), and not be currently taking Bactrim
Trial Length 32 weeks
Viral Load Between 5,000 and 1,000,000
T-Cells >100
Comments A pharmacokinetic and safety study of Procaine Hydrochloride for the treatment of elevated cortisol levels in HIV-infected individuals.
Contact Corrie Castro, AIDS Research Alliance, (310) 358-2429
ACTG 325
Meds Used Subcutaneous rhIL-12
Tx History Must continue current antiretroviral therapy and may not have a serious ongoing OI
Trial Length Eight weeks
Viral Load No requirement
T-Cells <50
Comments Phase 1 study to determine the tolerance of a range of multiple subcutaneous rhIL-12 dosing regimens. Participants will receive subcutaneous injections twice a week at UCLA
Contact Christine MacNaughton, UCLA, (310) 206-6414
Lymphoma
REVM10
Meds Used Infusion of stem cells with REVm10
Tx History Have documented non-Hodgkin's or HIV-related Lymphoma with poor prognosis and at least partial response to a standard chemotherapy regimen
Trial Length One year, possibly longer
Viral Load No requirement
T-Cells >100
Comments Open label, single arm phase I/II study to determine the feasibility and safety of infusion of stem cells engineered to contain the REVM10 with high-dose chemotherapy in individuals with HIV-related non-Hodgkin's Lymphoma. Participants will receive chemotherapy.
Contact Christine MacNaughton, UCLA, (310) 206-6414
CHOP/Rituxan
Meds Used CHOP chemotherapy and Rituxan
Tx History No prior chemotherapy
Trial Length Up to one year
Viral Load No requirement
T-Cells No requirement
Comments Phase II study of CHOP chemotherapy and Rituxan in newly diagnosed AIDS-related lymphoma
Contact Sue Cabriales, Brian Espina, LAC-USC, (323) 226-8270, (323) 865-0371
AMC-008
Meds Used Ifosfamide, Etoposide, IL-2, IL-12
Tx History Failed one or two chemotherapy treatments
Trial Length Up to one year
Viral Load No requirements
T-Cells No requirements
Comments Ifosfamide and Etoposide followed by IL-2 versus IL-12 versus observation. A phase II trial of IL-2, IL-12 or no additional therapy following response to Ifosfamide/Etoposide chemotherapy for refractory HIV-related non-Hodgkins lymphoma
Contact Sue Cabriales, Byron Espina, LAC-USC, (323) 226-8270, (323) 865-0371
PEG-L-Asparaginase
Meds Used PEG-L-Asparaginase (Onscapar)
Tx History Refractory lymphoma to any prior chemotherapy
Trial Length One year
Viral Load No requirement
T-Cells No requirement
Comments Phase I dose escalation study of PEG-L-Asparaginase (Onscapar), in the treatment of AIDS-related relapsed or refractory lymphoma. Peg-L-Asaparaginase will be given intramuscularly every two weeks.
Contact Maria Palmer, PA-C, LAC-USC, (323) 226-4578
Kaposi's Sarcoma
AMC 009
Meds Used Taxol, Doxil
Tx History Must be on stable antiretroviral treatment for longer than 14 days prior to the study and have no previous experience with chemotherapy
Trial Length One year
Viral Load No requirement
T-Cells No requirement
Comments Study to determine the efficacy of Taxol vs. Doxil for the treatment of HIV-related advanced KS
Contact Sue Cabriales, LAC USC/Norris Cancer Hospital, (323) 343 8270
Amifostine
Meds Used Amifostine, Taxol
Tx History Participants must have biopsy-proven KS with several measurable KS lesions, and not be taking any other experimental drugs or systemic gancyclovir
Trial Length 18 weeks
Viral Load No requirement
T-Cells No requirement
Comments Study to evaluate the short-term effectiveness and safety of amifostine in reducing the risk of low white blood cell counts in individuals being treated with Taxol for KS. Participants will be randomized to receive either amifostine before Taxol or Taxol
Contact Christine MacNaughton, UCLA, (310) 206-6414
AMC 0013
Meds Used Antiangiogenesis compound IM862
Tx History Must be stable on antiretrovirals treatment for at least eight weeks, have five or more KS lesions, and not receiving any other KS therapy
Trial Length Six months to one year
Viral Load No requirement
T-Cells No requirement
Comments Phase III, randomized, double blind study of antiangiogenesis compound IM862 for individuals with mucocutaneous KS
Contact Sue Cabriales, LAC USC/Norris Cancer Hospital, (323) 343-8270
SU4516
Meds Used SU4516
Tx History Must have at least five KS lesions, no pulmonary KS and at least 21 days rest after prior chemotherapy or radiation.
Trial Length Four weeks to one year, possibly more
Viral Load No requirement
T-Cells No requirement
Comments Phase I study of SU4516 AIDS-related KS Antiangiogenesis Factor. Dose escalation to maximum tolerated dose. Doses are given twice weekly intravenously
Contact Sue Cabriales, R.N., LAC-USC, (323) 343-8270; Christine MacNaughton, UCLA, (310) 206-6414
AMC 004
Meds Used Interferon alpha 2b (IFN-a2b), Norvir, Zerit
Tx History No concurrent acute OIs
Trial Length Participants will return for a study visit every 2 weeks for the first eight weeks, and then on a monthly basis
Viral Load No requirement
T-Cells No requirement
Comments Randomized study to determine the safety and tolerance of interferon-alpha 2b (IFN-a2b) in combination with Norvir and d4T in HIV-infected individuals with KS. IFN-a2b will be administered subcutaneously once a day
Contact Christine MacNaughton, UCLA, (310) 206-6414
CMV
Ocular Complications
Meds Used None, this is a follow-up study
Tx History Participants must have no pre-existing ocular problems
Trial Length Four years
Viral Load No requirement
T-Cells No requirement
Comments A multicenter study that follows individuals to record the incidents and frequencies of eye complications
Contact Michael Cornish, Ph.D., Jules Stein Eye Institute-UCLA, (310) 794-5608
CMARC-CMV
Meds Used None, this is a follow-up study
Tx History Participants must have a current or past diagnosis of CMV
Trial Length Six months
Viral Load No requirement
T-Cells No requirement
Comments Multicenter study to determine the factors that place individuals at risk for developing cytomegalovirus (CMV)
Contact Michael Cornish, Ph.D., Jules Stein Eye Institute-UCLA, (310) 794-5608
ACTG 379
Meds Used None, this is an observational study
Tx History Must be receiving a potent antiretroviral treatment regimen for more than eight weeks prior to study entry
Trial Length 48 weeks
Viral Load No requirement
T-Cells Originally below 50, but now above 100
Comments Discontinuation of maintenance therapy for CMV retinitis after immune reconstitution by potent antiretroviral therapy. HIV infected individuals with treated and healed non-immediate sight-threatening CMV retinitis.
Contact Gil Clemente, USC, (323) 343-8284; Christine MacNaughton, UCLA, (310) 206-6414
Cidofovir-Ganciclovir
Meds Used Cidofovir-Ganciclovir
Tx History Diagnosis of CMV retinitis and cannot have used cidofovir or the intraocular implant previously
Trial Length None, participants are followed for as long as they have the implant
Viral Load No requirement
T-Cells No requirement
Comments Randomized, multicenter trial to evaluate and compare IV cidofovir to the ganciclovir implant with oral ganciclovir to prevent vision loss. Cidofovir will be administered intravenously once weekly for two consecutive weeks and once every two weeks thereafter.
Contact Michael Cornish, Ph.D., Jules Stein Eye Institute-UCLA, (310) 794-5608
HIV & Hepatitis C
Meds Used Interferon, ribavirin
Tx History Interferon naive
Trial Length 72 weeks
Viral Load No requirement
T-Cells No requirement
Comments Study to compare the use of interferon vs. interferon with ribavirin for the treatment of Hepatitis C
Contact Connie Funk, R.N., USC, (323) 343-8282
H5230018 -- VALTREX
Meds Used Valaciclovir
Tx History Must have had four or more outbreaks within the past year or prior to beginning suppressive therapy and be on stable combination antiretroviral therapy for at least 2 months
Trial Length Six months
Viral Load No requirement
T-Cells No requirement
Comments Phase III study to evaluate the safety and efficacy of VALTREX therapy for the suppression of ano-genital herpes simplex virus (HSV) in HIV infected individuals. Participants will receive monthly blood work including viral load testing and T-cell counts,
Contact Michael Gonzalez, Pacific Oaks Research, (310) 360-8800
MAC
ACTG 393
Meds Used None
Tx History Must have DMAC diagnosis and treated for at least 12 months
Trial Length Study will last for 60 weeks.
Viral Load No requirement
T-Cells >100
Comments Study of discontinuation of maintenance therapy in individuals with disseminated Mycobacterium Avium Complex (DMAC), and currently receiving antiretroviral therapy for at least six weeks
Contact Frances Canchola, USC, (323) 343-8281
ACTG 341
Meds Used HAART
Tx History Inclusion criteria differs for each group, although all patients will be required to undergo 1-2 bone marrow biopsies
Trial Length up to 48 weeks
Viral Load No requirement
T-Cells No requirement
Comments Study of the natural history and pathogenesis of Mycobacterium avium Complex (MAC) and the impact of HAART on immune functions. Three groups of individuals with MAC will be evaluated, and will be reimbursed $250 per biopsy
Contact Connie Funk, R.N., B.S.N., USC, (323) 343-8282
ACTG 309
Meds Used INH, rifampin, PZA, ethambutol
Tx History Cannot have more than one week of therapy before entering the study and have a positive acid fast bacilli smear with TB cultures pending
Trial Length Eight weeks
Viral Load No requirement
T-Cells No requirement
Comments Study comparing how drugs against TB work in the body for people infected with both HIV and TB. Participants will receive standard therapy for TB with at least two of the following drugs, as determined by the clinician: INH, rifampin, PZA and ethambutol.
Contact Patsy Lopez, USC, (323) 343-8267
Candidiasis
ACTG 323
Meds Used Fluconazole
Tx History Must have had at least one or more documented episodes of oral thrush
Trial Length Two years
Viral Load No requirement
T-Cells
Comments Phase IV, randomized study of the use of fluconazole as chronic suppressive therapy versus episodic therapy in HIV-infected participants with recurrent oropharyngeal candidiasis
Contact DeAnn Diamond, R.N., USC, (323) 343-8239; Christine MacNaughton, UCLA, (310) 206-6414
Dementia
ACTG 301
Meds Used Oral memantine
Tx History No active OIs
Trial Length 16 weeks
Viral Load No requirement
T-Cells No requirement
Comments Phase II, randomized, double-blind, placebo-controlled study to assess the efficacy of oral memantine as a treatment for AIDS Dementia Complex (ADC). The effects of memantine on painful peripheral neuropathy will also be studied. Memantine will be dose es
Contact Christine MacNaughton, UCLA, (310) 206-6414
Central Nervous System
Meds Used None, this is an observational study
Tx History No requirement
Trial Length Five years or more
Viral Load No requirement
T-Cells
Comments Study to define the effects of HIV on the central nervous system. and will receive detailed medical and neurological testing
Contact Jacqui Pitt, R. N., Cedars Sinai, (310) 855-3755; Edward Lozano, M.D., LAC-USC Medical Center, (323) 343-8314
Human Growth Hormone
Meds Used Human growth hormone
Tx History Eligible participants must have documented unintentional weight loss of more than 10 percent and have been on stable antiviral therapy regimen for more than eight weeks prior to study entry
Trial Length 48 weeks
Viral Load No requirement
T-Cells No requirement
Comments Randomized, double-blind, placebo-controlled dose-ranging study of recombinant human growth hormone, injected subcutaneously. The primary endpoint will be at week 12, comparing a full or half dose to the placebo arm. Lean body mass changes will be evaluated.
Contact Rachel Belanger, R.N., Cedars Sinai, (310) 855-3755
For Children Only
ACTG P1008 (New Trial)
Meds Used Observational study
Tx History Must be on PCP/MAC prophylaxis and between the ages of 2 and 21 years old
Trial Length At least 104 weeks
Viral Load No requirement
T-Cells If between 2 and 6 years old, T-cell percentage must be 25 percent or higher. If between 6 and 21 years old, T-cell percentage must be at least 20 percent or higher. Must have two T-cell counts taken at least three months apart.
Comments Observational study to determine the impact and safety of discontinuing PCP and MAC prophylaxis. Hepatitis A vaccination will be given at entry and week 24 to measure response.
Contact Sarah Fox, R.N., CHLA, (323) 669-4537
ACTG 219
Meds Used This is an observational study
Tx History Study is open to perinatally infected infants and children currently or previously enrolled in ACTG treatment protocols
Trial Length Open-ended
Viral Load No requirement
T-Cells No requirement
Comments Prospective study to identify late outcomes and consequences related to HIV disease progression in children. Participants will receive free medical testing
Contact Sarah Fox, R.N., CHLA, (323) 669-4537




This article has been reprinted at The Body with the permission of AIDS Project Los Angeles (APLA).

  
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This article was provided by AIDS Project Los Angeles. It is a part of the publication Positive Living.
 

 

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