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Clinical Trials (in the Los Angeles Area)

May 1999

Metabolic Complications | Novel Combination Therapy | AIDS Vaccine | Resistance | Antiretrovirals | Immunotherapy | Anemia | Lymphoma | Kaposi's Sarcoma | Cytomegalovirus (CMV) | Opportunistic Infections (OI's) | Hepatitis B | Hepatitis C | Mycobacterium Avium Complex (MAC) | PCP Prophylaxis | Tuberculosis | Candidiasis | AIDS Dementia Complex | AIDS Wasting | For Children Only | Pregnant Women


Metabolic Complications

Amprenavir

Study looking at the effect of Agenerase (amprenavir) on carbohydrate and lipid metabolism. Participants will receive Agenerase 1, 200 mg twice a day (BID) plus Ziagen (abacavir) 300 mg BID plus Epivir (lamivudine, 3Tc) 150 mg BID. If individuals have received 3TC in the past they will receive d4T 40 mg BID. Participants must be protease inhibitor naïve. Study lasts 28 weeks.

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Hannah Edmondson-Melancon, R.N., USC, (323) 343-8280

Sustiva

Study looking at the effect of substituting Sustiva (efavirenz) for protease inhibitor (PI) therapy in individuals at increased risk for cardiovascular complications due to HIV-associated metabolic disorders. Participants must be on PI therapy for at least four months, have no experience with non-nucleoside reverse transcriptase inhibitors, an undetectable viral load, and abnormal levels of lipids in the blood or a high waist measurement compared to hip measurement. Participants will be randomized to remain on current therapy or switch to Sustiva. Study will last six months.

Patsy Lopez, USC, (323) 343-8277


Novel Combination Therapy

ICC 601

Phase II study to evaluate the safety and effectiveness of novel combination therapy with Videx (ddI), Zerit (d4T), Viramune (nevirapine) and MKC-442 with or without Hydroxyurea. Participants must be naïve to NNRTIs, MKC-442, ddI and/or d4T and are not responding to treatment that contains at least one protease inhibitor.

Donna Morales, R.N., Pacific Oaks Research, (310) 360-8800


AIDS Vaccine

VAX 004-AIDS Vaccine

Phase III, blinded, placebo-controlled study to determine the efficacy of AIDSVAX in adults at risk of sexually transmitted HIV-1 infection. Individuals must be HIV-negative. Study lasts 36 months.

Corie Castro, AIDS Research Alliance, (310) 358-2429


Resistance

d4T Phenotypic Resistance Study

Study to identify the presence of resistance mutations on the reverse transcriptase gene of HIV-1 among patients not responding to Zerit monotherapy or Zerit -containing treatment regimens who have limited prior exposure to Retrovir (ziduvodine, AZT). This study requires one-time visit for blood draw only. Participants must have been on Zerit-containing treatment for at least four months prior to screening, currently be taking Zerit and be naïve to Retrovir (less than two weeks' use). Participants will be compensated $25 for the visit.

Kai Gu, R.N., Pacific Oaks Research, (310) 360-8800

Antivirogram Study

Study to determine sensitivity of HIV to antiretroviral treatment. Participants must have viral load greater than 2, 000 copies and on antiretroviral therapy one month prior to study entry. Individuals must be receiving at least 2 NRTIs, only one protease inhibitor, no NNRTIs and must agree not to change therapy except as allowed by study protocol. Participants must agree not to have viral load measurements done except by study protocol. Study lasts 16 weeks.

Ruben Vidales, AHF Research Center, (213) 913-3953

Corie Castro, AIDS Research Alliance, (310) 358-2429

Donna Morales, R.N., Pacific Oaks Research, (310) 360-8800

Phenotypic Testing

Randomized study to determine if the use of a phenotype resistance assay will improve ability to choose antiretroviral regimens. Viral load must be higher than 400 and individuals must have had at least six months of prior antiviral therapy. Call for extended inclusion/exclusion criteria.

Sadia, Harbor UCLA, (310) 222-5291

Christine MacNaughton, UCLA, (310) 206-6414


Antiretrovirals

New Listing

Preveon (adefovir dipivoxil)

Study to measure antiviral activity and safety of Preveon as compared to placebo when added to stable highly active antiretroviral treatment (HAART). Participants must be on stable HAART for a minimum of 16 weeks prior to screening, have a viral load between 50 and 400 copies, CD4 count of 50 or greater, and no other serious infections requiring antibiotic/antiviral therapy. Participants will receive $20 for each completed visit.

Donna Morales, R.N., Pacific Oaks Research, (310) 360-8800

Agenerase (amprenavir, 141W94)

Open label, expanded access study to make Agenerase available to individuals who are not responding to other antiretrovirals. The study consists of three arms:

One for adults and children (4 years of age and older) to determine safety and tolerance of multiple oral doses of Agenerase. One for adults and adolescents (13 years of age and older) to determine efficacy of Agenerase in individuals who have not responded to protease inhibitor (PI) containing regimens. One to determine the effect of Agenerase on lipid metabolism.

Anastasia Vereninova, Lim-Keith Multispecialty

Medical Clinics, (213) 964-1440

ABT-378

Randomized, double-blind, Phase III study to compare the safety and antiviral activity of a new protease inhibitor, ABT-378, used with Zerit (stavudine, d4t) plus Epivir (lamivudine, 3TC) versus another regimen containing one protease inhibitor and two nucleoside reverse transcriptase inhibitors. Participants must have no previous experience with antiretroviral medication and have a detectable viral load greater than 400 copies. Study will last 48 weeks.

Miriam, Harbor-UCLA, (310) 222-3848

Kai Gu, R.N., Pacific Oaks Research, (310) 360-8800

Sustiva (efavirenz) Combination Therapy

Randomized study to compare duration of viral suppression of a continued protease inhibitor (PI) plus two nucleoside analog reverse transcriptase inhibitors (NRTI) regimen versus a Sustiva substitution regimen, and to evaluate the safety and tolerability of these regimens. Participants must have two consecutive plasma HIV-RNA levels less than 50 copies/mL quantified by the Roche Ultrasensitive Assay while on first antiretroviral regimen of one or two PIs plus two NRTIs.

Kai Gu, R.N., Pacific Oaks Research, (310) 360-8800

Crixivan/d4T/3TC vs. Crixivan/Viracept/d4T/3TC

Open label study to compare the safety and activity of Crixivan/d4T/3TC versus Crixivan/Viracept/d4T/3TC. Participants must have viral load equal to or greater than 10, 000 copies, CD4 count of 100 or more, be naïve to 3TC and PIs. Enrolled participants will receive a $40 transportation stipend for every scheduled visit. Study lasts 24 weeks.

Dewee McDermott, R.N., AHF Research Center, (323) 913-3953

AZT/Crixivan/delavirdine BID vs AZT/Crixivan/delavirdine TID

Open label study (with possible extension to 56 weeks) to evaluate the safety and tolerance of investigational combination therapies when taken twice a day (BID) versus three times a day (TID). Participants must have a viral load equal to or greater than 20, 000 copies, CD4 count of 50 or more, be naïve to 3TC, NNRTIs, PIs and no more than one month of AZT use. Enrolled participants will receive a $20 transportation stipend for every scheduled visit, once enrolled. Study lasts 32 weeks.

Dewee McDermott, R.N., AHF Research Center, (323) 913-3953

Lodenosine Combination Therapy

Phase II study to evaluate doses of lodenosine (a new nucleoside reverse transcriptase inhibitor) to be used as part of triple combination threapy. Three dose levels of lodenosine will be tested in combination with Zerit (stavudine, d4T) and Crixivan (indinavir). Participants must have viral load greater than 5, 000 copies, CD4 count of 200 or more and be naïve to NRTIs, NNRTIs and PIs (seven days use acceptable). Participants will be compensated $20 per treatment visit.

Kai Gu, R.N., Pacific Oaks Research, (310) 360-8800

ICC 602

Phase II study to evaluate the safety and effectiveness of novel combination therapy with Viracept (nelfinavir), Crixivan (indinavir) and Sustiva (efavirenz). Participants must have viral load greater than 10, 000 copies and be naïve to NNRTIs and PIs.

Donna Morales, R.N., Pacific Oaks Research, (310) 360-8800

ICC 603

Phase II study to evaluate the safety and effectiveness of novel combination therapy with ddI, d4T, delavirdine and MKC-442 with or without Hydroxyurea. Participants must have viral load between 5, 000 and 50, 000 copies/ml and be naïve to NNRTIs, ddI and/or d4T, and failing treatment regimens that contain at least one protease inhibitor.

Donna Morales, R.N., Pacific Oaks Research, (310) 360-8800

ICC 604

Phase II study to evaluate the safety and effectiveness of novel combination therapy with Preveon (adefovir dipivoxil), ddI, efavirenz and 3TC. Participants must have viral load greater than 5, 000 copies/ml, CD4 counts greater than 50 T-cells, naïve to NNRTIs, NRTIs and study medications.

Donna Morales, R.N., Pacific Oaks Research, (310) 360-8800

ICC 605

Phase II study to evaluate the safety and effectiveness of novel combination therapy with adefovir dipivoxil, abacavir, efavirenz and amprenavir. Participants must have viral load greater than 2, 000 copies, be naïve to NNRTIs and study medications, and failing treatment that contains at least one protease inhibitor other than amprenavir.

Donna Morales, R.N., Pacific Oaks Research, (310) 360-8800

ACTG 400

Comparative study of salvage antiretroviral therapies for HIV-infected individuals with evidence of nelfinavir treatment failure as reflected by plasma viral load of more than 1, 000 copies/ml. No prior exposure to nevirapine, delavirdine or efavirenz is allowed. No prior exposure (less than seven days (to amprenavir, saquinavir, indinavir, ritonavir is allowed). Study lasts 48 weeks.

Gil Clemente, R.N., USC, (323) 343-8284

ACTG 398

Study comparing amprenavir vs. amprenavir plus saquinavir, indinavir or nelfinavir in HIV-infected individuals currently failing indinavir, ritonavir, saquinavir (soft gel capsule) or nelfinavir as evidenced by viral load of more than 1, 000 copies/ml. All participants will receive amprenavir, abacavir, efavirenz and adefovir dipivoxil. Study lasts 48 weeks.

Christine MacNaughton, UCLA, (310) 206-6414

ACTG 384

Randomized, double-blind, six-arm study of protease inhibitors and/or non-nucleoside reverse transcriptase inhibitors with dual nuceloside in initial therapy of HIV infection. Study includes various combinations of ddI, efavirenz, nelfinavir, AZT, D4T and 3TC. Study lasts three years.

Connie Olson, USC, (323) 343-8279

Miriam, Harbor UCLA, (310) 222-3848

Christine MacNaughton, UCLA, (310) 206-6414

FTC 303

Randomized, open-label study of FTC (a new nucleoside analog) versus 3TC for people on a stable triple antiretroviral regimen containing 3TC and a protease inhibitor. Viral load must be 400 or less.

Connie Olson, R.N., USC, (323) 343-8279

Preveon (adefovir dipivoxil)

Expanded access study to make Preveon (adefovir dipivoxil) available to individuals who have failed combination therapy with comercially available antiretrovirals and have limited treatment options. T-cell count must be 50 or less within the past two months. Viral load must be 30, 000 or more (by PCR), or 15, 000 or more (by bDNA) within the past two months.

Marsue Davidson, Kraus Medical Partners, (323) 930-2324 or (800) 860-0700

Anastasia Vereninova, Lim-Keith Multispecialty Medical Clinics, (323) 964-1440

MERCK 075

Study to determine whether indinavir (Crixivan) plus efavirenz (DMP 266) plus adefovir dipivoxil (bis-Pom) is safe and effective for lowering viral load to undetectable levels in patients who are protease inhibitor-naïve or who have failed treatment with nelfinavir. Participants must have a CD4 count greater than 50, have a viral load greater than or equal to 10, 000, have at least 16 weeks of treatment with any nucleoside analogues, be naïve to protease inhibitors, or have failed nelfinavir, and have no prior use of any NNRTIs. Women must have a negative serum pregnancy test and willing to use birth control.

Irene Teran, R.N., USC, (323) 343-8278

Viracept (nelfinavir)

Randomized study to compare nelfinavir at 750 mg three times daily in combination with AZT at 300 mg twice daily, 3TC at 150 mg twice daily, versus nelfinavir at 750 mg three times daily and ddI at 400mg once daily with d4T at 40 mg twice daily. Limited previous RTI and protease inhibitor therapy required. Viral load should be at least 2, 000 copies and CD4 count should be at least 100. Study lasts 48 weeks.

Sandra, Harbor UCLA (310) 222-5291

ACTG 368

Study to compare the virilogic response between 1592U89 (abacavir) used in combination with open label Crixivan and Sustiva (efavirez/DMP-266 vs. placebo, Crixivan and Sustiva. All participants will start on Crixivan and Sustiva. If anyone still has a detectable viral load at week 16, they will be offered all three drugs for the remainder of the study. Eligible participants must have a T-cell count equal to or less than 200 and have used AZT/3TC or d4T/3TC for three months or more.

Christine MacNaughton, UCLA, (310) 206-6414

Preveon (adefovir dipivoxil)

Study to evaluate the safety and tolerance of Preveon (adefovir dipivoxil), an experimental nucleotide analog, at two doses when given in combination with two other anti-HIV drugs. Eligible participants will have received prior therapy with AZT, ddC, ddI, d4T or 3TC, but cannot have used protease inhibitors. The study will compare the changes in T-cells and viral load levels with the different drug combinations and how long these changes last. Study lasts 48 weeks. Participants who complete treatment will be offered Preveon in a roll-over study.

Christine MacNaughton, UCLA, (310) 206-6414

Fortovase (saquinavir soft gel capsule)

Study to evaluate the effectiveness of Fortovase (soft gel capsule saquinavir) in combination with other approved antiretrovirals. Individual must be treatment-naïve or fit one of the following criteria: antiretroviral-experienced with less than two weeks of treatment with protease inhibitors or have used reverse transcriptase inhibitors for more than three months. No T-cell requirement. Viral load measurement must be at least 5, 000. Participants will be randomized into three groups. Periodic exams and blood tests are required.

Eileen Guido, R.N., Beer Medical Group, (323) 937-5151


Immunotherapy

Procaine Hydrochloride

Pharmacokinetic and safety study of Procaine Hydrochloride for the treatment of elevated cortisol levels in HIV-infected individuals. Participants must have a minimum of eight weeks' stable antiretroviral therapy, no active opportunistic infections and not be currently taking Bactrim.

Corrie Castro, AIDS Research Alliance, (310) 358-2429

Stem Cell Transplant

Open label, Phase I/II study to determine the safety of infusion of stem cells engineered to contain the anti-HIV genes RevM10 and antisense poll (pollAS) and to determine the extent of bone marrow suppression required to achieve engrafment of these cells. The effects of this treatment on CD4 count and plasma HIV RNA will also be assessed. Participants must have CD4 count between 100 and 500, no history of significant opportunistic infection, and no treatment with an investigational antiretroviral agent within 30 days prior to screening. Study is not open to pregnant or nursing women.

Christine MacNaughton, UCLA, (310) 206-6414

IL-12/ACTG 325

Phase I study to determine the tolerance of a range of multiple subcutaneous rhIL-12 dosing regimens in people with fewer than 50 T-cells. Participants must continue their current antiretroviral therapy and may not have a serious ongoing opportunistic infection. Participants will receive subcutaneous injections twice a week at UCLA. Study lasts eight weeks.

Christine MacNaughton, UCLA, (310) 206-6414

IL-2/ACTG 328

Phase II study to compare two different ways of administering IL-2 with Highly Active Antiretroviral Therapy (HAART) vs. HAART alone and to see how many patients have a 50 percent or more increase in T-cells after one year. IL-2 will be given through IV or subcutaneous injections in addition to HAART. HAART will consist of two nucleoside analogs, one of which must be new to the patient, and Crixivan for 12 weeks. If viral load is below 5, 000 copies, patients will be randomized to HAART alone or IL-2. Eligible patients must have a T-cell count between 50 and 350 and no prior use of protease inhibitors or IL-2. Visits occur monthly and the study lasts for 84 weeks.

Christine MacNaughton, UCLA, (310) 206-6414

IL-2

Phase II study of low-dose interleukin 2 given as a subcutaneous injection to patients who achieve partial remission after initial chemotherapy. Study lasts for up to one year.

Maria Palmer, PA-C, LAC-USC, (323) 226-4578


Anemia

Procrit

Open label study to evaluate the effectiveness of Procrit in alleviating anemia and improving the quality of life. Participants will receive either subcutaneous injections of 100 units/kg three times a week vs. 40, 000 units once a week. $25 transportation stipend will be provided for each visit once enrolled. Study lasts 16 weeks.

Edwin Graham, R.N., AHF Research Center, (213) 913-3953


Lymphoma

REVM10

Open label, 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 and G-CSF growth factor to assess the sensitivity of the disease to chemotherapy. Bone marrow recovery will be conducted to collect peripheral blood stem cells (PBSC). These cells will be transduced with RevM10 and used for support with high-dose chemotherapy. Participants have CD4 count greater than 100, have documented non-Hodgkin's or HIV-related Lymphoma with poor prognosis and at least partial response to a standard chemotherapy regimen.

Christine MacNaughton, UCLA, (310) 206-6414

CHOP/Rituxan

Phase II study of CHOP chemotherapy and Rituxan in newly diagnosed AIDS-related lymphoma. Study will last up to one year.

Sue Cabriales, LAC USC, (323) 343-8270

Byron Espina, LAC USC, (323) 865-0371

AMC-008

Ifosfamide and Etoposide followed by IL-2 versus observation. Phase II trial of IL-2, IL-12 or no additional therapy following response to Ifosfamide/Etoposide chemotherapy for refractory HIV-related non-Hodkins lymphoma. Study will last up to one year.

Sue Cabriales, LAC USC, (323) 343-8270

Byron Espina, LAC USC, (323) 865-0371

Stem Cell Transplant

High-dose chemotherapy and autologous peripheral stem cell transplantation for HIV-related lymphomas. Phase I trial of comparative marketing using a ribozyme gene and a neutral gene. Study will last up to two years.

Byron Espina, LAC USC, (323) 865-0371

Ribozyme Gene Therapy

Phase II, high-dose chemotherapy and stem cell transplantation for non-Hodgkin's lymphoma. Patients will receive a gene therapy targeted to HIV replication.

John Zaia, M.D., City of Hope National Medical Center, Duarte (626) 301-8434

CHOP + HAART

Phase II and pharmacokinetic study of CHOP chemotherapy in combination with Crixivan, 3TC and d4T for newly diagnosed AIDS-related lymphoma. Study lasts for four to six months.

Maria Palmer, PA-C, LAC-USC, (323) 226-4578

PEG-L-Asparaginase

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.

Maria Palmer, PA-C, LAC-USC, (323) 226-4578

DaunoXome

Phase II study of liposomal DaunoXome given intravenously every three weeks in individuals with relapsed or refractory intermediate or high grade AIDS-related lymphoma.

Sue Cabriales, LAC USC, (323) 343-8270

Byron Espina, LAC USC, (323) 865-0371


Kaposi's Sarcoma

New Listing

AMC-009

Study to determine the efficacy of Taxol vs. Doxil for the treatment of HIV-related advanced KS. Participants must be on stable antiretroviral treatment for 14 days prior to the study and have no previous experience with chemotherapy.

Sue Cabriales, LAC USC/Norris Cancer Hospital, (323) 343-8270

Amifostine (formerly WR-2721)

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 Kaposi's sarcoma (KS). Participants will be randomized to receive either amifostine before Taxol or Taxol alone. Chemotherapy will be given every three weeks for a maximum of six cycles. Participants must have biopsy-proven KS with several measurable KS lesions, and not be taking any other experimental drugs or systemic ganciclovir.

Christine MacNaughton, UCLA, (310) 206-6414

AMC 0011

Phase I study of oral antiangiogenesis compound Col-3 in individuals with KS. Participants must have 5 or more lesions with no pulmonary KS or severe edema.

Sue Cabriales, LAC USC/Norris Cancer Hospital, (323) 343-8270

AMC 0013

Phase III, randomized, double-blind study of antiangiogenesis compound IM862 for individuals with mucocutaneous KS. Participants must be stable on antiretroviral treatment for at least eight weeks, have five or more KS lesions, and not receiving any other KS therapy

Sue Cabriales, LAC USC/Norris Cancer Hospital, (323) 343-8270

AMC 016

Study of oral antiangiogenesis compound PTK 787/ZK 222584 for individuals with KS. Participants must be stable on antiretroviral treatment for at least eight weeks and have five or more KS lesions.

Sue Cabriales, LAC USC/Norris Cancer Hospital

(323) 343-8270

SU4516

Phase I study of SU4516 AIDS-related KS Antiangiogenesis Factor. Dose escalation to maximum tolerated dose. Participants must have at least fuv KS lesions, no pulmonary KS and at least 21 days rest after prior chemotherapy or radiation. Doses are given twice weekly intravenously.

Sue Cabriales, R.N., LAC-USC, (323) 343-8270

Taxol

Patients must have advanced Kaposi's Sarcoma with 25 lesions or more, with or without visceral disease. A minimum of 10 cycles and prior chemotherapy allowed.

Sue Cabriales, R.N., LAC-USC, (323) 343-8270

AMC 004

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. Participants will return for a study visit every two weeks for the first 8 weeks, and then on a monthly basis. No T-cell restrictions. No active OIs.

Christine MacNaughton, UCLA, (310) 206-6414


CMV

Ocular Complications

Multicenter longitudinal study that follows individuals for up to four years to record the incidents and frequencies of eye complications. Participants must have no pre-existing ocular problems.

Michael Cornish, Ph.D., Jules Stein Eye Institute, UCLA (310) 794-7868

CMARC-CMV

Multicenter study to determine the factors that place individuals at risk for developing cytomegalovirus (CMV). Participants must have a current or past diagnosis of CMV.

Michael Cornish, Ph.D., Jules Stein Eye Institute, UCLA (310) 794-7868

Valganciclovir vs. IV ganciclovir

Study will compare the effectiveness of the oral prodrug of ganciclovir (valganciclovir) versus the currently available intravenous ganciclovir. Participants must be HIV positive with newly diagnosed CMV retinitis and no prior treatment with any anti-CMV medications.

Stone Blacka, Office of David Boyer, M.D., (310) 854-6201

ACTG 379

Discontinuation of maintenance therapy for Cytomegalovirus (CMV) retinitis after immune recon-stitution by potent antiretroviral therapy in HIV-infected individuals with treated and healed non-immediate sight-threatening CMV retinitis. Individuals must be receiving a potent antiretroviral treatment regimen for more than eight weeks prior to study entry and have a CD4 count of more than 100. After 48 weeks of study, participants will be followed every four weeks or to time of progression.

Gil Clemente, USC, (323) 343-8284

Christine MacNaughton, UCLA, (310) 206-6414

Lobucavir

Pilot placebo-controlled trial of antiviral activity of oral lobucavir versus oral ganciclovir in individuals receiving intraocular therapy for CMV. Limited number of enrollments.

Ramon Bautista, Office of Brian Terry, M.D., (626) 584-1200

Stone Blacka, Office of David Boyer, M.D., (310) 854-6201

Cidofovir-Ganciclovir

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 weekly for two consecutive weeks and every two weeks thereafter. The ganciclovir implant will be surgically implanted in the eyes and oral ganciclovir will be taken three times a day. Eligible participants must have a CMV retinitis diagnosis and cannot have used cidofovir or the intraocular implant previously.

Michael Cornish, Ph.D., Jules Stein Eye Institute, UCLA (310) 794-7868


O.I.s

Levofloxacin

Multicenter study to evaluate the safety and efficacy of levofloxacin (500 mg), once daily in the treatment of community acquired pneumonia in adults. Eligible participants will receive levofloxacin orally or by intravenous infusion for 10 to 14 days, as in or out patients. Must be 18 years of age or older, have clinical symptoms and evidence on chest X-ray of community acquired pneumonia within 48 hours, T-cell counts above 200. Participants cannot have had a previous allergic or serious adverse reaction to any member of the quinolone class of antimicrobials, severe renal failure or pregnancy.

Vicky, Karen or Monica, Sherman Oaks Hospital Research Institute, (818) 205-1902


Hepatitis B

Monoclonal Antibody (OST 577)

Study to determine the effectiveness of a monoclonal antibody (OST 577) in combination with 3TC for the treatment of Hepatitis B in individuals who are HIV-infected. Individuals must have more than 150 CD4 cells. Participants will receive one of two different doses of the monoclonal antibody via intravenous infusion every other day for 12 days and then once every three weeks for the reminder of the six months. Participants will have to be available for blood tests for another six months after treatment is discontinued. Participants will be paid $1, 000 on completion of the study.

Christine MacNaughton, UCLA, (310) 206-6414


Hepatitis C

New Listing

Intron A, Ribavirin

Study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of Intron A (interferon alpha-2) plus Ribavirin in pediatric patients with chronic hepatitis C infection.

Karen Clodfelter, USC Maternal Child Program, (323) 226-5068


MAC

ACTG 393

Discontinuation-of-maintenance therapy study in individuals with disseminated Mycobacterium Avium Complex (DMAC). Participants must have DMAC diagnosis, treated for at least 12 months, have a CD4 count of more than 100 T-cells, and currently receive antiretroviral therapy for at least six weeks. Study will last for 60 weeks.

Frances Canchola, USC, (323) 343-8281

ACTG 341

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 for up to 48 weeks. Inclusion criteria differs for each group, although all patients will be required to undergo 1-2 bone marrow biopsies, and will be reimbursed $250 per biopsy.

Connie Funk, R.N., B.S.N., USC, (323) 343-8282


PCP Prophylaxis

ACTG 888

Impact of discontinuing PCP prophylaxis in patients who have increases in CD4 counts to greater than 200 cells. No prior documented PCP in the last six months. Study will last 2-1/2 years.

Hannah Edmondson-Melancon, R.N., USC (323) 343-8280

Connie Funk, R.N., USC (323) 343-8282


Tuberculosis

ACTG 309

Study comparing how drugs against TB work in the body for people infected with both HIV and TB. Patients will receive standard therapy for TB with at least two of the following drugs, as determined by the clinician: INH, rifampin, PZA and ethambutol. Patients will know what medications they are taking. Two study visits are required (weeks 2 and 6) and will last 8 to 10 hours long involving blood collection at several different times. Patients will be paid $25 per day on those evaluations. Drugs are provided at the study site. Patients cannot have more than one week of therapy before entering the study and have a positive acid fast bacilli smear with TB cultures pending. Study lasts eight weeks.

Patsy Lopez, USC, (323) 343-8267


Candidiasis

ACTG 323

Phase IV, randomized study of the use of fluconazole as chronic suppressive therapy versus episodic therapy in HIV-infected participants with recurrent oropharyngeal candidiasis. T-cell count must be 150. Participants must have had at least one or more documented episodes of oral thrush. Study lasts two years.

DeAnn Diamond, R.N., USC, (323) 343-8239

Christine MacNaughton, UCLA, (310) 206-6414


AIDS Dementia Complex

A1455-064

16-week, open label study to evaluate the role of Zerit (d4T, Stavudine) in the treatment of AIDS Dementia Complex. Participants must have evidence of dementia, newly diagnosed or already established. Participants must be d4T naïve and must have been on a stable antiretroviral regimen for a minimum of eight weeks. Lumbar punctures are included in the protocol.

Corie Castro, AIDS Research Alliance, (310) 358-2429

ACTG 301

Twenty-four week study to determine if Memantine can help improve symptoms of AIDS Dementia. Participants must be on stable antiretroviral therapy for six weeks and must consent to neurological exam, neuropsychological testing, a spinal tap and MRI. Compensation provided. Also needed are patients without dementia for this study who must consent to neurological testing, spinal tap and MRI. Compensation provided.

Sally or Mario, Harbor UCLA, (310) 222-3848

ACTG 301

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-escalated for the first three weeks until a maximally tolerated dose is reached. Study lasts for 16 weeks, but all patients will be able to receive open label memantine after 12 weeks. No active OIs.

Christine MacNaughton, UCLA, (310) 206-6414

Central Nervous System

Study to defibe the effects of HIV on the central nervous system. Participants must have CD4 count less than 50 and will receive detailed medical and neurological testing.

Jacqui Pitt, R.N., Cedars Sinai, (310) 855-3755

Edward Lozana, M.D., LAC-USC, (323) 224-5424

Dee Frater, R.N., UCLA, (800) 791-4966


AIDS Wasting

Thalidomide

Study to assess the effectiveness of Thalidomide when used to reduce the rate of weight loss associated with HIV. Individuals must be Thalidomide-naïve, have no significant nerve damage in arms or legs and have no blood abnormalities.

Anastasia Vereninova, Lim-Keith Multispecialty Medical Clinics, (323) 964-1440

Human Growth Hormone

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 to determine the optimal dose of growth hormone at the end of week 12. All participants receiving placebo will be randomized to a full or half dose from week 12 through 48. Body weight will be monitored at four-week intervals. 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. Study lasts 48 weeks.

Christine MacNaughton, UCLA, (310) 206-6414

Jacqui Pitt, R.N., Cedars Sinai, (310) 855-3755


For Children Only

ACTG 382

Phase I/II open label study of Sustiva in combination with Viracept for children between 3 months and 8 years old. Sustiva is a NNRTI which inhibits HIV production from infected cells.

Sheri Plameck, USC Maternal Child Program, (323) 226-5068

ACTG 351, part 2

Phase I/II, open-label study of high dose CD4-IgG2 given intravenously. Treatment will be given once weekly. Study is open to HIV-infected children 2-12 years of age who are clinically stable and on stable antiretroviral regimen for three months and have a viral load greater than 10 000.

Sheri Plameck, CHLA, (323) 669-4537

CMV

Randomized trial of intravenous gancyclovir vs. observation for newborns born with congenital CMV infection.

Sheri Plameck, USC Maternal Child Program, (323) 226-5068

ACTG 397

Study of saquinavir soft-gel capsule in combination with two other NRTIs of the physician's choice. Nelfinavir will be added to some patient's medication regimen.

Melissa Scanlon, R.N., USC Maternal Child Program, (323) 226-5068

Preveon (adefovir dipivoxil)

Study to evaluate the safety of adefovir dipivoxil. Participants must be 13 years of age or older and have failed other combinations of anti-HIV medications.

Judy Eyssallenne, USC Maternal Child Program, (323) 226-5068

ACTG 345

Phase I/II study for HIV-infected infants and children age 1 month to 2 years of age. Children will receive ritonavir, 3TC and AZT. Study lasts 104 weeks.

Sheri Plambeck, USC Maternal Child Program, (323) 226-5068

ACTG 321

Phase I study of 1592 (abacavir) with standard AZT therapy to infants and babies born to HIV-infected mothers. A single dose will be administered to infants three to four weeks of age. Later, part two of this study will be available, which is six weeks of 1592 given with standard AZT treatment to infants starting at 0-48 hours of age. Mothers can pre-register when they are 37 weeks pregnant.

Rosslyn Davidson, USC Maternal Child Program, (323) 226-5068

ACTG 331

Study of effect of AZT on infants born prematurely to HIV-infected mothers. Premature infants, 34 weeks gestation or less and less than five days old are eligible.

Rosslyn Davidson, USC Maternal Child Program, (323) 226-5068

ACTG 247

Study of high-calorie and standard-calorie formula for newborns of HIV-infected mothers. After eight weeks, the infants will be assigned by chance to discontinue or continue the study for 20 more weeks. Infants must be less than or equal to two weeks old and must weigh at least four pounds. Mothers may not breastfeed. Mothers may enroll in the study while they are pregnant.

Rosslyn Davidson, USC Maternal Child Program, (323) 226-5068

ACTG 377

Phase I/II randomized, open-label study comparing four antiretroviral regimens containing com-binations of d4T, 3TC, nevirapine, Viracept and Norvir. HIV-infected, clinically stable children, four months to 17 years old who have been treated continuously with the same antivirals for 16 weeks or more may enroll.

Sarah Fox Wheeler, R.N., CHLA, (323) 669-4537

ACTG 366

Phase I/II open-label study comparing four drug combination therapies in HIV-infected children between six months and 21 years old with rapidly progressive or advanced HIV disease. Enrollment based on antiretroviral experience.

Sheri Plambeck, USC Maternal Child Program, (323) 226-5068

ACTG 254

Phase II/III, double-blind study to compare the prevention of serious bacterial infections using Mepron and Zithromax versus Bactrim in children between 2 and 19 years old. Children must be at risk for developing PCP and require prophylaxis as defined by current guidelines for PCP and haven't taken Mepron or Zithromax for more than three weeks. Visits are scheduled for every four weeks for the first four months and then every eight weeks. The study will last for two years upon completion of enrollment.

Sarah Fox Wheeler, R.N., CHLA, (323) 669-4537

Rosslyn Davidson, USC Maternal Child Program, (323) 226-5068


For Women Only

Testosterone

Randomized study to evaluate the effect of testosterone replacement on weight maintenance, muscle function and quality of life. Participants must be between the ages of 18 and 50, and have experienced weight loss. Study will last for 14 weeks. Participants will be compensated $750 for completion of study.

Marjan, Harbor-UCLA, (310) 222-8152

ACTG 293

Open-label, randomized, Phase III trial of oral accutane vs. observation to determine the efficacy of accu-tane for the prevention of progression of mild cervical dysplasia (CIN-1). Patients must not be pregnant, over 13 years old and have CIN-1/HPV. Both groups will receive gynecological care.

Hannah Edmondson, R.N., B.S.N., USC, (323) 343-8280

Sheri Plambeck, USC Maternal Child Program, (323) 226-5068

Oxandrolone

Randomized, double-blind, placebo-controlled study to determine the safety and efficacy of Oxandrolone on body weight in HIV-infected women. Patients must have unintentionally lost 10 to 20 percent of body weight. Study lasts 24 weeks; the first 12 weeks involve placebo, then open-label. $20 transportation stipend once enrolled.

Dewee McDermott, R.N., AHF Research Center, (323) 913-3953


Pregnant Women

ACTG 316

Phase III study of nevirapine vs. placebo for the prevention of maternal-fetal transmission of HIV. Nevirapine or placebo are taken orally by women in labor. The infant will also receive a single dose of nevirapine or placebo at 48-72 hours of age. Mothers will be encouraged to also take AZT during pregnancy and while in labor. Follow-up study visits are at two days, six-to-nine days, one month, three months and six months after birth.

Linda Grisolano, USC Maternal Child Program, (323) 226-5068

ACTG 353

Phase I study of Viracept, AZT/3TC in HIV-infected pregnant women and their infants. Participants will receive these medications from the start of the study to 12 weeks after delivery. Newborns will begin taking Viracept, AZT/3TC when they can take liquids and continue for six weeks. Mothers will have study visits every two weeks until week 36 of their pregnancy, then every week until the start of labor. Infants will have study visits at eight days, three weeks, six weeks, three months and six months of age. Mothers cannot have any past treatment with protease inhibitors, 3TC, NNRTIs or active alcohol or substance abuse, active OIs, or chronic malabsorption or diarrhea.

Sheri Plambeck, USC Maternal Child Program, (323) 226-5068

ACTG 332

Phase I/II open label study of d4T and 3TC in HIV-infected pregnant women and their infants. Study is designed for women who are intolerant to AZT. However, the infants will receive standard AZT along with d4T and 3TC after birth.

Sheri Plambeck, USC Maternal Child Program, (323) 226-5068


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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