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HIV Clinical Trials in the Los Angeles Area

NZTA-4008 (New Trial)
Meds UsedEpivir, AZT, Sustiva
Tx HistoryAntiretroviral naive
Trial Length48 weeks
Viral Load>400
T-Cells>100
CommentsStudy to determine the efficacy of Epivir once a day ion combination with AZT and Sustiva vs. twice a day.
ContactKai Gu, Pacific Oaks Research, (310) 360-8800
ABT-378 (New Trial)
Meds UsedABT-378
Tx HistoryNNRTI-naive and prior use with only one PI
Trial Length48 weeks
Viral Load>1,000
T-CellsNo requirement
CommentsPhase IV study to evaluate ABT-378 in PI-experienced participants
ContactKai Gu, Pacific Oaks Research, (310) 360-8800
Norvir-Crixivan Intensification
Meds UsedNorvir/ Crixivan
Tx HistoryAll participants must be on Crixivan, on the same regimen for three months or longer, and Norvir naive
Trial Length48 weeks
Viral LoadBetween 50 and 50,000
T-CellsNo requirement
CommentsNorvir/Crixivan intensification therapy for HIV-infected individuals. Crixivan will be taken twice daily at elevated doses along with a lower dose of Norvir.
ContactJacqui Pitt, R.N., Cedars Sinai, (310) 855-3755; Ruth Pinter, R.N., Beer Medical Group, (323) 937-5151
Resistance
Phenotypic Testing
Meds UsedPhenotype test
Tx HistoryMust have at least six months of prior antiviral therapy
Trial LengthOne year
Viral Load>400
T-CellsNo requirement
CommentsRandomized 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
ContactSadia, Harbor UCLA, (310) 222-5291; Christine MacNaughton, UCLA, (310) 206-6414
Viracept-Combivir + Remune
Meds UsedViracept, Combivir, Remune
Tx HistoryAntiretroviral naive
Trial Length48 weeks
Viral Load>10,000
T-Cells>250
CommentsRandomized, adjuvant-controlled study to compare the virologic and immunologic effects of HAART plus Remune vs. HAART plus Incomplete Freund's adjuvant
ContactCorie Castro, AIDS Research Alliance, (310) 358-2429
Zerit Extended Release
Meds UsedZerit, approved antiretrovirals
Tx HistoryNRTI-naive
Trial Length48 weeks
Viral Load>5,000
T-Cells>100
CommentsEvaluation of the safety and antiviral activity of Zerit extended release vs. immediate release formulations, each as part of potent antiretroviral combination therapy
ContactCorie Castro, AIDS Research Alliance, (310) 358-2429
ACTG 383/Hepatitis C
Meds UsedThis is an observational study, approved antiretrovirals from a co-enrollment of another study
Tx HistoryMust have a diagnosis of Hepatitis C and HIV, less than 2 weeks of antiretroviral therapy
Trial Length48 weeks
Viral Load>2,500
T-CellsNo requirement
CommentsTo 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.
ContactSally or Mario, Harbor-UCLA, (310) 222-3848; Connie Funk, R.N., USC, (323) 343-8282
ACTG 371
Meds UsedCombivir, Ziagen, Agenerease
Tx HistoryTreatment naive
Trial Length48 weeks of treatment plus follow up
Viral Load>2,000 within seven days of study entry
T-CellsNo requirement
CommentsStudy 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
ContactConnie Funk, R.N., USC, (323) 343-8282
Metabolic Disorders
Amprenavir
Meds UsedAgenerase, Ziagen, Epivir or Zerit
Tx HistoryPI naive
Trial Length28 week
Viral LoadNo requirement
T-Cells>100
CommentsStudy 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)
ContactHannah Edmondson-Melancon, R.N., USC, (323) 343-8280
Sustiva
Meds UsedSustiva plus your current antiviral therapy
Tx HistoryMust 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 LengthSix months
Viral Load<50
T-CellsNo requirement
CommentsStudy 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
ContactPatsy Lopez, USC, (323) 343-8277
L-756423
Meds UsedL-756423, Crixivan, Zerit, Epivir
Tx HistoryLess than two weeks prior therapy with antiretrovirals and no prior treatment with PIs or Epivir
Trial Length48 weeks or longer
Viral Load>10,000
T-Cells>100
CommentsStudy 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
ContactChristine MacNaughton, UCLA, (310) 206-6414
Adefovir
Meds UsedAdefovir
Tx HistoryMust be on stable HAART for a minimum of 16 weeks prior to screening and no other serious infections requiring antibiotic/antiviral therapy
Trial Length48 weeks
Viral LoadBetween 50 and 400 copies
T-Cells50 or greater
CommentsStudy 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
ContactGary Aquino, L.V.N., Pacific Oaks Research, (310) 360-8800
Sustiva Combination Therapy
Meds UsedSustiva
Tx HistoryNNRTI naive
Trial Length48 weeks
Viral LoadMust have two consecutive viral load tests under 50
T-CellsNo requirement
CommentsRandomized 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
ContactKai Gu, R.N., Pacific Oaks Research, (310) 360-8800
BID vs. TID
Meds UsedRetrovir, Crixivan, Rescriptor
Tx HistoryNaive to 3TC, NNRTIs, PIs, and limited experience with AZT (no more than one month).
Trial Length32 weeks (with possible extension to 56 weeks)
Viral Load>20,000
T-Cells>50
CommentsOpen 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.
ContactDoug Bowden, AHF Research Center, (323)913-3953
ACTG 400
Meds UsedApproved anitretrovirals
Tx HistoryNaive to Viramune, Rescriptor or Sustiva is allowed. No prior exposure (less than seven days) to Agenerase, Invirase, Crixivan or Norvir is allowed
Trial Length48 weeks
Viral Load>1000
T-CellsNo requirement
CommentsComparative 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
ContactConnie Funk, R.N., USC, (323) 343-8282
ACTG 384
Meds UsedStudy includes various combinations of Videx, Retrovir, Zerit, Epivir, Sustiva, Viracept
Tx HistoryMust have less than seven days prior therapy with any antiretroviral medications
Trial LengthThree years
Viral Load<500
T-CellsNo requirement
CommentsRandomized double-blind, six-arm study of PIs and/or NNRTIs in combination with NRTIs in initial therapy of HIV infection
ContactChristine MacNaughton, UCLA, (310) 206-6414; Miriam, Harbor-UCLA, (310) 222-3848: Connie Olson, USC, (323) 343-8279
Adefovir Expanded Access
Meds UsedAdefovir
Tx HistoryIndividuals who have failed combination therapy with commercially available antiretrovirals and have limited treatment options
Trial LengthUntil FDA approved
Viral LoadMust be 30,000 or more (by PCR), or 15,000 or more (by bDNA) within the past two months
T-CellsMust be 50 or less within the past two months
CommentsSee Tx history
ContactLeanne 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 UsedInterleukin-2
Tx HistoryStable antiviral therapy of more than three drugs for longer than four months
Trial LengthFive years
Viral Load<10,000
T-Cells>50 and <300
CommentsPhase 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.
ContactPetra, Harbor, UCLA, (310) 222-3848
Procaine Hydrochloride
Meds UsedProcaine Hydrochloride plus Videx and Hydroxyurea
Tx HistoryParticipants must have a minimum of eight weeks stable antiretroviral therapy, no active opportunistic infections (OI), and not be currently taking Bactrim
Trial Length32 weeks
Viral LoadBetween 5,000 and 1,000,000
T-Cells>100
CommentsA pharmacokinetic and safety study of Procaine Hydrochloride for the treatment of elevated cortisol levels in HIV-infected individuals.
ContactCorrie Castro, AIDS Research Alliance, (310) 358-2429
ACTG 325
Meds UsedSubcutaneous rhIL-12
Tx HistoryMust continue current antiretroviral therapy and may not have a serious ongoing OI
Trial LengthEight weeks
Viral LoadNo requirement
T-Cells<50
CommentsPhase 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
ContactChristine MacNaughton, UCLA, (310) 206-6414
Lymphoma
REVM10
Meds UsedInfusion of stem cells with REVm10
Tx HistoryHave documented non-Hodgkin's or HIV-related Lymphoma with poor prognosis and at least partial response to a standard chemotherapy regimen
Trial LengthOne year, possibly longer
Viral LoadNo requirement
T-Cells>100
CommentsOpen 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.
ContactChristine MacNaughton, UCLA, (310) 206-6414
CHOP/Rituxan
Meds UsedCHOP chemotherapy and Rituxan
Tx HistoryNo prior chemotherapy
Trial LengthUp to one year
Viral LoadNo requirement
T-CellsNo requirement
CommentsPhase II study of CHOP chemotherapy and Rituxan in newly diagnosed AIDS-related lymphoma
ContactSue Cabriales, Brian Espina, LAC-USC, (323) 226-8270, (323) 865-0371
AMC-008
Meds UsedIfosfamide, Etoposide, IL-2, IL-12
Tx HistoryFailed one or two chemotherapy treatments
Trial LengthUp to one year
Viral LoadNo requirements
T-CellsNo requirements
CommentsIfosfamide 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
ContactSue Cabriales, Byron Espina, LAC-USC, (323) 226-8270, (323) 865-0371
PEG-L-Asparaginase
Meds UsedPEG-L-Asparaginase (Onscapar)
Tx HistoryRefractory lymphoma to any prior chemotherapy
Trial LengthOne year
Viral LoadNo requirement
T-CellsNo requirement
CommentsPhase 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.
ContactMaria Palmer, PA-C, LAC-USC, (323) 226-4578
Kaposi's Sarcoma
AMC 009
Meds UsedTaxol, Doxil
Tx HistoryMust be on stable antiretroviral treatment for longer than 14 days prior to the study and have no previous experience with chemotherapy
Trial LengthOne year
Viral LoadNo requirement
T-CellsNo requirement
CommentsStudy to determine the efficacy of Taxol vs. Doxil for the treatment of HIV-related advanced KS
ContactSue Cabriales, LAC USC/Norris Cancer Hospital, (323) 343 8270
Amifostine
Meds UsedAmifostine, Taxol
Tx HistoryParticipants must have biopsy-proven KS with several measurable KS lesions, and not be taking any other experimental drugs or systemic gancyclovir
Trial Length18 weeks
Viral LoadNo requirement
T-CellsNo requirement
CommentsStudy 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
ContactChristine MacNaughton, UCLA, (310) 206-6414
AMC 0013
Meds UsedAntiangiogenesis compound IM862
Tx HistoryMust be stable on antiretrovirals treatment for at least eight weeks, have five or more KS lesions, and not receiving any other KS therapy
Trial LengthSix months to one year
Viral LoadNo requirement
T-CellsNo requirement
CommentsPhase III, randomized, double blind study of antiangiogenesis compound IM862 for individuals with mucocutaneous KS
ContactSue Cabriales, LAC USC/Norris Cancer Hospital, (323) 343-8270
SU4516
Meds UsedSU4516
Tx HistoryMust have at least five KS lesions, no pulmonary KS and at least 21 days rest after prior chemotherapy or radiation.
Trial LengthFour weeks to one year, possibly more
Viral LoadNo requirement
T-CellsNo requirement
CommentsPhase I study of SU4516 AIDS-related KS Antiangiogenesis Factor. Dose escalation to maximum tolerated dose. Doses are given twice weekly intravenously
ContactSue Cabriales, R.N., LAC-USC, (323) 343-8270; Christine MacNaughton, UCLA, (310) 206-6414
AMC 004
Meds UsedInterferon alpha 2b (IFN-a2b), Norvir, Zerit
Tx HistoryNo concurrent acute OIs
Trial LengthParticipants will return for a study visit every 2 weeks for the first eight weeks, and then on a monthly basis
Viral LoadNo requirement
T-CellsNo requirement
CommentsRandomized 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
ContactChristine MacNaughton, UCLA, (310) 206-6414
CMV
Ocular Complications
Meds UsedNone, this is a follow-up study
Tx HistoryParticipants must have no pre-existing ocular problems
Trial LengthFour years
Viral LoadNo requirement
T-CellsNo requirement
CommentsA multicenter study that follows individuals to record the incidents and frequencies of eye complications
ContactMichael Cornish, Ph.D., Jules Stein Eye Institute-UCLA, (310) 794-5608
CMARC-CMV
Meds UsedNone, this is a follow-up study
Tx HistoryParticipants must have a current or past diagnosis of CMV
Trial LengthSix months
Viral LoadNo requirement
T-CellsNo requirement
CommentsMulticenter study to determine the factors that place individuals at risk for developing cytomegalovirus (CMV)
ContactMichael Cornish, Ph.D., Jules Stein Eye Institute-UCLA, (310) 794-5608
ACTG 379
Meds UsedNone, this is an observational study
Tx HistoryMust be receiving a potent antiretroviral treatment regimen for more than eight weeks prior to study entry
Trial Length48 weeks
Viral LoadNo requirement
T-CellsOriginally below 50, but now above 100
CommentsDiscontinuation 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.
ContactGil Clemente, USC, (323) 343-8284; Christine MacNaughton, UCLA, (310) 206-6414
Cidofovir-Ganciclovir
Meds UsedCidofovir-Ganciclovir
Tx HistoryDiagnosis of CMV retinitis and cannot have used cidofovir or the intraocular implant previously
Trial LengthNone, participants are followed for as long as they have the implant
Viral LoadNo requirement
T-CellsNo requirement
CommentsRandomized, 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.
ContactMichael Cornish, Ph.D., Jules Stein Eye Institute-UCLA, (310) 794-5608
HIV & Hepatitis C
Meds UsedInterferon, ribavirin
Tx HistoryInterferon naive
Trial Length72 weeks
Viral LoadNo requirement
T-CellsNo requirement
CommentsStudy to compare the use of interferon vs. interferon with ribavirin for the treatment of Hepatitis C
ContactConnie Funk, R.N., USC, (323) 343-8282
H5230018 -- VALTREX
Meds UsedValaciclovir
Tx HistoryMust 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 LengthSix months
Viral LoadNo requirement
T-CellsNo requirement
CommentsPhase 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,
ContactMichael Gonzalez, Pacific Oaks Research, (310) 360-8800
MAC
ACTG 393
Meds UsedNone
Tx HistoryMust have DMAC diagnosis and treated for at least 12 months
Trial LengthStudy will last for 60 weeks.
Viral LoadNo requirement
T-Cells>100
CommentsStudy of discontinuation of maintenance therapy in individuals with disseminated Mycobacterium Avium Complex (DMAC), and currently receiving antiretroviral therapy for at least six weeks
ContactFrances Canchola, USC, (323) 343-8281
ACTG 341
Meds UsedHAART
Tx HistoryInclusion criteria differs for each group, although all patients will be required to undergo 1-2 bone marrow biopsies
Trial Lengthup to 48 weeks
Viral LoadNo requirement
T-CellsNo requirement
CommentsStudy 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
ContactConnie Funk, R.N., B.S.N., USC, (323) 343-8282
ACTG 309
Meds UsedINH, rifampin, PZA, ethambutol
Tx HistoryCannot have more than one week of therapy before entering the study and have a positive acid fast bacilli smear with TB cultures pending
Trial LengthEight weeks
Viral LoadNo requirement
T-CellsNo requirement
CommentsStudy 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.
ContactPatsy Lopez, USC, (323) 343-8267
Candidiasis
ACTG 323
Meds UsedFluconazole
Tx HistoryMust have had at least one or more documented episodes of oral thrush
Trial LengthTwo years
Viral LoadNo requirement
T-Cells
CommentsPhase IV, randomized study of the use of fluconazole as chronic suppressive therapy versus episodic therapy in HIV-infected participants with recurrent oropharyngeal candidiasis
ContactDeAnn Diamond, R.N., USC, (323) 343-8239; Christine MacNaughton, UCLA, (310) 206-6414
Dementia
ACTG 301
Meds UsedOral memantine
Tx HistoryNo active OIs
Trial Length16 weeks
Viral LoadNo requirement
T-CellsNo requirement
CommentsPhase 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
ContactChristine MacNaughton, UCLA, (310) 206-6414
Central Nervous System
Meds UsedNone, this is an observational study
Tx HistoryNo requirement
Trial LengthFive years or more
Viral LoadNo requirement
T-Cells
CommentsStudy to define the effects of HIV on the central nervous system. and will receive detailed medical and neurological testing
ContactJacqui Pitt, R. N., Cedars Sinai, (310) 855-3755; Edward Lozano, M.D., LAC-USC Medical Center, (323) 343-8314
Human Growth Hormone
Meds UsedHuman growth hormone
Tx HistoryEligible 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 Length48 weeks
Viral LoadNo requirement
T-CellsNo requirement
CommentsRandomized, 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.
ContactRachel Belanger, R.N., Cedars Sinai, (310) 855-3755
For Children Only
ACTG P1008 (New Trial)
Meds UsedObservational study
Tx HistoryMust be on PCP/MAC prophylaxis and between the ages of 2 and 21 years old
Trial LengthAt least 104 weeks
Viral LoadNo requirement
T-CellsIf 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.
CommentsObservational 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.
ContactSarah Fox, R.N., CHLA, (323) 669-4537
ACTG 219
Meds UsedThis is an observational study
Tx HistoryStudy is open to perinatally infected infants and children currently or previously enrolled in ACTG treatment protocols
Trial LengthOpen-ended
Viral LoadNo requirement
T-CellsNo requirement
CommentsProspective study to identify late outcomes and consequences related to HIV disease progression in children. Participants will receive free medical testing
ContactSarah 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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