Published in the Bulletin of Experimental Treatments for AIDS 1999 Year-End issue, by the San Francisco AIDS Foundation.

Year-End 1999 Table of Contents

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Open Clinical Trials for HIV/AIDS Treatments

David Townley

All listings are taken from Trials Search, an online database of open clinical trials for HIV-infected individuals. Trials Search, a comprehensive source for clinical trial information, is available at http://hivinsite.ucsf.edu/tsearch. The Community Consortium of the University of California at San Francisco (UCSF) Positive Health Program at San Francisco General Hospital Medical Center provides this free service. For further information about individual listings, call the number provided or consult Trials Search.

The American Foundation for AIDS Research (amfAR) also maintains a searchable database of clinical trials, available through their Treatment Directory at www.amfar.org. Individuals who do not have access to the Internet can obtain information on all government-funded trials by calling the AIDS Clinical Trials Information Service (ACTIS) toll-free at 1-800-TRIALS-A (1-800-874-2572). Protocol (study) numbers, if available, are provided in parentheses at the end of each listing.

The purpose of this study is to see what effect protease inhibitors have on sugar and fat metabolism and body composition in people who are starting protease inhibitor treatment. Before beginning treatment, participants will be hospitalized in the General Clinical Research Center at San Francisco General Hospital to undergo five days of detailed studies of sugar and fat metabolism and measurements of total and regional body fat content. After completing these studies, trial subjects will start their antiretroviral therapy, which must contain a protease inhibitor, and return to the Research Center periodically over the next 18 months for follow-up measurements. Participants will be paid $2,000 for completing this study. There is no CD4 cell requirement. Prior use of protease inhibitors, severe diarrhea, nausea or vomiting, or the use of anabolic medicines within 30 days of study entry is not allowed. Participants may not be pregnant. The study is being conducted in San Francisco (415-206-5882).

This study will investigate the safety and effectiveness of a new protease inhibitor (ABT-378/r) combined with nevirapine and two nucleoside analogs (NRTIs, such as AZT [Retrovir] and 3TC [Epivir]) compared with a regimen of one or two other protease inhibitors plus nevirapine and two NRTIs. (ABT-378 is administered with a low dose of ritonavir [Norvir], hence the name ABT-378/r.) All participants will take nevirapine and two NRTIs. In addition, subjects will be assigned by chance to take either ABT-378/r or one or two other protease inhibitors selected by the study investigator. Subjects will know which medications they are taking. Study visits will be once a month; participants will take study medications for at least 48 weeks. There is no CD4 cell requirement but volunteers must have a viral load between 1,000 and 500,000 copies/mL. Volunteers must be on a stable (unchanged) antiretroviral regimen that includes two NRTIs and one protease inhibitor for at least 12 weeks prior to study entry. Participants may not be pregnant, have active infections, or have used any NNRTIs for more than seven days. The study is being offered in Atlanta (404-876-2317 ext. 328), Boston (617-414-5404 or 888-253-2712 ext. 218), Chicago (773-244-5804), Cincinnati (513-584-2245), Dallas (214-520-1810), Detroit (313-916-1132), Los Angeles (310-360-8800 or 310-222-3838), New Orleans (504-584-3608), New York (212-420-4519 or 212-746-4161), Portland (503-229-8428), and Tampa Bay (813-875-4048 ext. 229 or 813-870-4760). (M98-888)

This study will compare the new protease inhibitor BMS-232632 with nelfinavir (when both are combined with ddI and d4T) for safety, tolerability, and effectiveness in lowering the amount of HIV in the blood. Subjects are assigned by chance to receive one of three doses of BMS-232632 with ddI and d4T or nelfinavir, ddI, and d4T. People assigned to take BMS-232632 will not know which dose they are receiving until the study ends. Study visits will take place every two weeks for the first month, then once a month until week 16, then every two months thereafter. The study will last 48 weeks. Volunteers must have a CD4 cell count of at least 100 cells/mm³ and a viral load between 2,000 and 200,000 copies/mL. Participants may not be pregnant or have active infections, pancreatitis, or hemophilia. Previous use of any antiretroviral treatments (except up to seven days' use of any NRTI) is not allowed. Trial sites include Birmingham (205-975-9128), Chicago (312-942-5000 ext. 50486), Cleveland (216-368-2437), Dallas (214-520-1810), Denver (303-372-5535), Galveston (409-747-0241), New York (212-420-4519), and San Francisco (415-476-9296 ext. 312). (A1424-007)

The purpose of this study is to compare a continuing protease inhibitor regimen with a regimen containing efavirenz in people who have achieved undetectable viral loads (i.e., less than 50 copies/mL). Subjects are assigned by chance either to continue taking their protease inhibitor treatment combined with two NRTIs or to switch to efavirenz combined with two NRTIs. Participants will know which medications they are taking. Only efavirenz will be supplied by the study. Trial visits will take place once a month; the study lasts 48 weeks. There is no CD4 cell count requirement but participants must have two consecutive tests showing viral loads below 50 copies/mL. Prior use of efavirenz or use of saquinavir (Fortovase) as a single protease inhibitor is not allowed. Participants may not have active infections, hepatitis, pancreatitis, or any cancers requiring chemotherapy. The study is being offered in Atlanta (404-876-2317 ext. 357), Chicago (773-244-5804 or 312-942-5000 ext. 50486), Cincinnati (513-584-2245), Fort Lauderdale (954-565-4030), Houston (713-793-4149), Jacksonville (904-798-4810), Kansas City (816-756-5116), Newport Beach (949-646-1111), Philadelphia (215-349-8092), San Diego (619-235-4211), San Francisco (415-221-4810 ext. 3763), and Washington, DC (202-994-2417). (DMP 266-049)

This study will monitor the treatment preferences of HIV-infected people who are taking indinavir and ritonavir twice a day compared with those who are taking indinavir three times a day. The study also will determine if these two treatments are effective in maintaining an undetectable viral load as part of a highly active antiretroviral therapy (HAART) regimen. Subjects are assigned by chance to switch to the indinavir/ritonavir combination or to continue taking indinavir (three times a day) with their current antiretroviral therapy. Study visits will be once a month; the study lasts 24 weeks. There is no CD4 cell count requirement but volunteers must have an undetectable viral load (i.e., less than 50 copies/mL) and currently be taking indinavir every eight hours along with two NRTIs. Volunteers may not be pregnant. Trial locations include Los Angeles (323-869-5429), San Diego (619-235-0501), Tampa Bay (813-875-4048 ext. 229 or 813-870-4760), and Washington, DC (202-331-3888). (M99-047, also known as the NICE study)

DPC 961 is an experimental non-nucleoside reverse transcriptase inhibitor (NNRTI) from DuPont Pharmaceuticals. This study will compare DPC 961 with efavirenz when both are combined with AZT and 3TC. All participants will take AZT and 3TC while being assigned by chance to take either one of three doses of DPC 961 or efavirenz. Neither participants nor their doctors will know if they are taking DPC 961 or efavirenz for the first four weeks of the study. After four weeks, those people assigned to take efavirenz will continue to do so and all subjects taking one of the DPC 961 doses will be given the same dose of DPC 961, which will be determined from the pharmacokinetic studies done during the first four weeks. Study visits will take place once a month; the study lasts at least 48 weeks. Volunteers must have a CD4 cell count of at least 250 cells/mm³ and a viral load of at least 1,000 copies/mL. Participants may not be pregnant, have any cancers requiring chemotherapy, or have had any vaccinations within three weeks of study entry. Prior use of antiretroviral medications is not allowed. The study is being offered in Cincinnati (513-584-6377), Detroit (313-916-1132), Houston (713-830-3018), and Tampa Bay (813-870-4760). (DPC 961-201)

T-20 is a fusion inhibitor, a new class of antiretroviral drug that inhibits HIV replication at a different site than currently available antiretrovirals. This study will compare three different doses of T-20 when combined with abacavir, amprenavir, ritonavir, and efavirenz for safety and effectiveness in lowering the amount of HIV in the blood. All participants will take abacavir, amprenavir, ritonavir, and efavirenz; they also will be assigned by chance either to receive one of three doses of T-20 or not to receive T-20. T-20 will be given by intradermal (under the skin) injection twice a day. Subjects will know which medications and which doses they are receiving. Study visits will be once a month; the study lasts 48 weeks. Volunteers must demonstrate a viral load between 400 and 100,000 copies/mL and have used at least one protease inhibitor for a minimum of 16 weeks prior to study entry. Participants may not be pregnant or have active infections, chronic diarrhea, or any cancers other than Kaposi's sarcoma (KS) of the skin or basal cell carcinoma. Prior use of any NNRTIs, abacavir, or amprenavir is not allowed. The study is being offered in Atlanta (404-876-2317 ext. 328), Los Angeles (310-360-8800), New York (212-263-8707), Pittsburgh (412-647-8125), San Diego (619-543-8080), San Francisco (415-353-0800 or 415-476-9296 ext. 312 or 415-353-5623), and St. Louis (314-454-0538). (T20-206)

Immunotherapy

This study will determine whether adding Remune (an immune-based therapy) to HAART is more effective than HAART alone in reducing and maintaining the viral load at an undetectable level. All subjects will begin the study by taking nelfinavir and Combivir. After eight weeks, those people who have a viral load of more than 2,000 copies/mL will be discontinued from the study. Persons with a viral load of 2,000 copies/mL or less will be assigned by chance to receive Remune or placebo. Remune and its placebo will be given by injection into a muscle starting at week 9 and every 12 weeks thereafter. Study visits will be once a month; the study lasts at least 48 weeks. Volunteers must have a CD4 cell count of at least 250 cells/mm³ and at least 10,000 copies/mL of HIV RNA. Participants may not be pregnant, have any cancers requiring chemotherapy, or have had any immunizations within six weeks of study entry. Prior use of Remune or use of immunomodulators within 30 days of study entry is not allowed. Study sites include Houston (713-830-3014), Nashville (615-936-1164), and Palm Beach (561-689-0606). (AG1661-202)

The purpose of this study is to determine if CPI-1189 is safe and well tolerated when given in multiple doses to HIV-infected individuals with cognitive and motor impairment. Participants are assigned by chance to receive one of two doses of CPI-1189. Subjects will not know which dose they are receiving for the first ten weeks. After ten weeks, all subjects will receive 100 mg of CPI-1189 daily. CPI-1189 is a pill taken once a day. Participants will undergo a lumbar puncture (spinal tap) at baseline and at week 10. During a lumbar puncture, a needle is inserted into the spinal column between two vertebrae and a small amount of fluid is removed. Study visits will take place at weeks 2, 6, 10, and 13; the study will last 22 weeks. Volunteers must have evidence of mild to moderate cognitive and motor impairment and be on stable antiretroviral therapy for at least six weeks prior to study entry. Participants may not have active opportunistic infections (OIs) or major psychiatric disorders. The study is being offered in Baltimore (410-955-1852), Chicago (312-908-4511), New York (212-305-9194), Rochester (716-275-1279), and San Diego (619-543-5036).

This study will determine which dose of PTK787/ZK222584 is well tolerated, see if it is safe when taken orally every day, and investigate its pharmacokinetics. The study also will see if PTK787/ZK222584 has any effect on the growth of KS lesions as well as on HIV and the immune system. This is a dose-ranging study, which means the first people to enroll will receive the lowest dose of PTK787/ZK222584. If no serious side effects are seen, the next group of volunteers will receive a higher dose, and so forth until the highest dose researchers plan to study has been given. PTK787/ZK222584 is a capsule taken at the same time every day. Participants will take PTK787/ZK222584 in 28-day cycles. Subjects will participate in three all-day clinic visits for multiple blood tests; in addition, each volunteer will have one biopsy (surgical removal of a small piece) of a KS lesion. Persons who show a complete or partial response to PTK787/ZK222584 may continue treatment indefinitely. Volunteers must have biopsy-proven KS of the skin with at least five lesions and be on stable antiretroviral therapy for at least eight weeks prior to study entry. Volunteers may not have CNS lymphoma or OIs, or have undergone recent chemotherapy or radiation therapy. Participants may not be pregnant. Study locations include Boston (617-414-5404 or 617-724-9189), Los Angeles (323-343-8270), and San Francisco (415-567-5581 or 415-476-9296 ext. 301). (AMC 011)

The purpose of this study is to see if Lamictal helps relieve pain associated with peripheral neuropathy and improves the quality of life of HIV positive people. Participants are assigned by chance to receive Lamictal or placebo; subjects will not know which they are taking until the study ends. There will be six study visits during this 11-week trial. Subjects will have the option to continue taking Lamictal for an additional three months. Volunteers must have moderate to severe peripheral neuropathy diagnosed by a neurologist but may not have active infections. Prior use of Lamictal is not allowed. The study is being offered in Baltimore (410-955-1895), Chicago (312-908-4511), and Rochester (716-273-2114). (LAM 40006)

The purpose of this study is to determine if a high-quality whey protein supplement is effective at maintaining or increasing the amount of lean body mass (such as muscle) in persons who have lost weight but whose weight is currently stable. Volunteers are assigned by chance to receive the protein-enriched supplement or a supplement that lacks the specific whey protein. Participants will not know which treatment they are receiving until the study ends. Both supplements are to be mixed with water and taken twice a day between meals for 12 weeks. Study visits will take place 2, 6, and 12 weeks after the supplements are started. Subjects will be required to keep a three-day food diary that will be reviewed by a dietitian. Body composition will be measured by Bioelectrical Impedance Analysis (BIA), whereby an electrode is placed on one wrist and one ankle and a very weak, undetectable electrical current is passed briefly through the body. Participants must have a viral load of less than 5,000 copies/mL and a documented weight loss of greater than 3% of total body weight. Volunteers may not have active infections, oral/esophageal diseases that interfere with eating, or an allergy to milk products. Volunteers also may not be pregnant. Study sites include Baltimore (410-955-4370), Honolulu (808-737-2751), and New Orleans (504-584-3605). (ACTG 392)

This study will investigate whether taking protease inhibitors together with lipid-lowering drugs ("statins") has an effect on the levels of statins found in the blood compared with taking these drugs alone. Participants are assigned by chance to one of four groups. Group 1 will take ritonavir, saquinavir, and pravastatin. Group 2 will take ritonavir, saquinavir, and simvastatin. Group 3 will take ritonavir, saquinavir, and atorvastatin. Group 4 will take nelfinavir and pravastatin. Participants in groups 1, 2, and 3 will take their respective lipid-lowering drugs on days 1-4; then on days 5-14 they will stop the lipid-lowering drugs and take only ritonavir and saquinavir. On days 15-18 they will resume taking their lipid-lowering drugs together with ritonavir and saquinavir. Participants in group 4 will take only nelfinavir on days 1-14; then on days 15-18 they will take nelfinavir and pravastatin. On days 4 and 18 all participants will spend the entire day at the Clinical Research Center for a series of blood tests. The study lasts 25 days. Participants must be HIV negative and weigh at least 110 pounds. Volunteers may not be pregnant. The study is being offered in San Francisco (415-476-9296 ext. 362) and Seattle (206-731-3183). (ACTG A5047)

This study will evaluate immune system function in children and adolescents taking HAART. Specifically, investigators will monitor overall CD4 cell increases and plasma viral load, as well as the return rate of both naive and memory CD4 cells. Children and adolescents who are ready to begin taking HAART are eligible to enter this study. After one month of taking HAART, participants will be tested for HIV plasma levels. Subjects whose HIV blood levels have decreased ten-fold since trial screening will continue in the study and undergo blood tests and physical examinations once a month until week 48. Participants will also receive six immunizations (three for hepatitis A and three for tetanus). After receiving all vaccines, subjects will go to the clinic for follow-up at weeks 52, 76, and 100. The study lasts approximately two years. Participants must be between 4 and 17 years of age, have less than 10% CD4 cells (out of a total number of lymphocytes), and have received three tetanus vaccines, at least one within the previous five years. Participants may not be pregnant, have active infections, or display immunity to hepatitis A. Current use of hydroxyurea is not allowed. The study is being offered in Birmingham (205-558-2328), Chicago (773-880-3669), New York (212-305-5000 or 212-939-4045), Philadelphia (215-590-2262), San Diego (619-543-8080 ext. 204), San Francisco (415-476-6480), and Washington, DC (202-884-2837). (ACTG P1006)

This study will determine whether VZV vaccine is safe and able to prevent herpes zoster (shingles) in HIV-infected children and adolescents between the ages of 2 and 18 who have already had chickenpox. Eligible volunteers will be given the VZV vaccine by intradermal injection. Blood tests and physical examinations will be given at weeks 4, 8, 12, 24, 36, 52, and 78 following the initial immunization; subjects who tolerated the initial immunization will be given a second dose at the week-8 study visit. All subjects will have a final study visit at week 104. The trial will last two years. Participants must have been on a stable antiretroviral regimen for at least three months and have had 10-15% CD4 cells (out of a total number of lymphocytes) for at least six months at trial entry. Volunteers may not be pregnant or have active infections, a fever over 101° F, chickenpox or herpes zoster exposure within four weeks of trial entry, past episodes of shingles, or prior immunizations with VZV vaccine. Study sites include Atlanta (404-616-9786), Baltimore (410-706-8220), Boston (617-355-8198), Chicago (773-880-3669), Denver (303-861-6751), Houston (713-770-1319), New York (212-263-6426), Oakland (510-428-3885 ext. 2827), and Washington, DC (202-884-2837). (ACTG 391)

David Townley is a staff member of the Community Consortium of the UCSF AIDS Program at San Francisco General Hospital.

Page last updated 8 January 2000