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Published in the Bulletin of Experimental Treatments for AIDS Spring 2001 issue, by the San Francisco AIDS Foundation. |
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| The following listings were gathered from a variety of sources.Trials Search, an online | |
| database of open clinical trials related to HIV/AIDS, is available on the HIV InSite Web site: hivinsite.ucsf.edu/tsearch.This free service is provided by the University of California, San Francisco (UCSF) Positive Health Program at San Francisco General Hospital Medical Center. The American Foundation for AIDS Research (amfAR) also maintains a searchable database of clinical trials, available through their Treatment Directory at www.amfar.org. In addition, ClinicalTrials.gov-a free service of the U.S. National Institutes of Health (NIH)-is a clearinghouse of trials relating to all health conditions; it can be found at clinicaltrials.gov. Persons without 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). Call the telephone number(s) listed for further information about specific trials featured in this article. Protocol (study) numbers, if available, are also provided in parentheses at the end of each listing. | |
This Phase III, double-blinded, randomized study will compare the effectiveness and tolerability of three protease-sparing regimens as initial (first-line) treatment regimens. Participants will be assigned to one of three groups. Group 1 will take Trizivir and two placebos (sugar pills substituted for study drugs); Group 2 will take Trizivir, efavirenz, and one placebo; and Group 3 will take Combivir, efavirenz, and one placebo. The study will last for three years, with clinic visits required every two weeks for four visits, followed by every four weeks for four visits, and every eight weeks thereafter. There are no CD4 cell or viral load requirements. Exclusion criteria include prior use of any antiretroviral treatment and use of an immunomodulator or HIV vaccine within 30 days of study entry. Study locations include Los Angeles (323-343-8288), Miami (305-243-3838), New York (212-420-4519), and San Francisco (415-514-0550). (A5095)
This Phase II pilot study will evaluate whether the addition of one of three supplemental anti-HIV drugs to participants’ established regimens can effectively lower viral load. All interested participants will receive a phenotypic test during the screening process to determine their sensitivity to the study drugs; inclusion or exclusion may be based on the results of this test. Eligible participants will be assigned at random to one of three groups. Group A will add abacavir to their current antiretroviral regimen, Group B will add amprenavir, and Group C will add ddI and hydroxyurea. All participants will know which medications they are taking. The study will provide only the supplemental anti-HIV drugs; other antiretroviral medications must be obtained via prescription or other means. The study will last 48 weeks, with clinic visits required every two weeks for the first month, then once a month for the next six months, followed by once every other month. Eligible participants must have at least 100 CD4 cells/mm3 and a viral load between 500 and 10,000 copies/mL that has been maintained for less than 16 weeks, after having been undetectable on at least two previous tests while taking their current antiretroviral regimen. Participants must have been taking their current regimen for at least 24 weeks prior to study entry. Treatment must include at least three approved antiretrovirals, of which one must be a protease inhibitor (PI). Exclusion criteria include pregnancy or breast-feeding, any immunization within 21 days of study entry, and any cancer requiring chemotherapy, including Kaposi’s sarcoma (KS). The study is being offered in Chicago (312-908-9636) and New York (212-263-8707). (ACTG A5601)
This Phase III, open-label study will assess the effectiveness and safety of T-20, an experimental fusion inhibitor, in combination with an optimal anti-HIV regimen, and compare the combination with the regimen without T-20, in persons with prior antiretroviral experience. All interested participants will receive genotypic and phenotypic tests during the screening process to determine which antiretroviral drugs would be most beneficial to them. The test results will help inform the participants’ and their providers’ decisions about their optimal drug regimen, which should consist of three to five medications. Eligible participants will be assigned at random to take T-20 in combination with their regimen or to take their regimen alone. All participants will know to which group they have been assigned. T-20 is administered as an injection under the skin twice a day. The study will last 48 weeks, with required clinic visits. After 48 weeks, all participants will be offered T-20. Eligible participants must have a viral load of at least 5,000 copies/mL and at least six months’ prior use of one or more nucleoside reverse transcriptase inhibitors (NRTIs), one or more non-nucleoside reverse transcriptase inhibitors (NNRTIs), and two or more PIs. Exclusion criteria include pregnancy or breast-feeding, prior use of T-20 or T-1249, active substance abuse, and active, untreated opportunistic infections (OIs). Study locations include Boston (617-636-5311), Galveston (409-747-0241), Miami (305-856-2171), New York (212-305-7897), Phoenix (602-307-5330), San Diego (619-543-8080), and San Francisco (415-353-0800). (T20-301/NV16054)
This Phase III, randomized study will evaluate the effectiveness of IL-2 combined with HAART in slowing HIV disease progression. All participants will be assigned to receive IL-2 or to continue taking their current antiretroviral regimens. In addition to taking their HAART regimens, participants assigned to take IL-2 will receive injections of the drug twice a day for five consecutive days every eight weeks. The study will last from four to six years, with clinic visits required every two months for the first year. Eligible participants must have 50–300 CD4 cells/mm3 and a viral load below 10,000 copies/mL. Exclusion criteria include pregnancy or breast-feeding, active AIDS-defining illnesses, current use of hydroxyurea, and any cancers. Study locations include Albuquerque (505-272-9390), Atlanta (404-876-2317), Berkeley (510-204-4109), Chapel Hill (919-970-2627), Chicago (773-244-5804), Cleveland (216-368-2437), Detroit (313-916-1132), Galveston (409-747-0241), Hershey (717-532-4213), Los Angeles (310-206-6414), New York (212-420-9390), and San Francisco (415-353-6215). (CS-L2-9901)
This randomized, partially blinded study will evaluate the safety and effectiveness of a course of initial treatment with the combination regimen of 3TC, d4T, and abacavir plus amprenavir/ritonavir, followed by discontinuation, in persons with acute (early) HIV infection or recent seroconversion. All participants will receive the antiretroviral combination twice a day for one year, along with required study visits for physical examinations and blood tests. If by week 48 participants have a viral load below 200 copies/mL and are still taking abacavir, they will be assigned at random to one of three groups. Group A will take Combivir, abacavir, and amprenavir; Group B will take Combivir, abacavir, and a placebo; and Group C will take abacavir, amprenavir, and a placebo. Participants will be told whether or not they are taking amprenavir. At week 88, participants with viral loads below 50 copies/mL will discontinue treatment and be followed for an additional 24 weeks. Participants with viral loads above 50 copies/mL will be followed through week 112, after which they will be offered four treatment options. The study will last approximately two years. Eligible participants must have a viral load of at least 2,000 copies/mL within seven days of study entry and a negative ELISA (HIV antibody test), or a positive ELISA but negative or indeterminate Western blot (confirmatory) test. Exclusion criteria include prior use of any antiretroviral treatment. Study locations include Boston (617-726-3819), Honolulu (808-737-2751), Miami (305-243-3838), New York (212-305-7897), Providence (401-793-9193), San Francisco (415-514-0550), and San Juan (787-767-9193). (ACTG 371)
This study
will evaluate the effectiveness of immediately changing to a new antiretroviral
regimen or of starting a new treatment regimen after having undergone
a four-month STI, in people with multidrug-resistant HIV. All participants
will receive a genotypic test as part of the screening process. If the
test results indicate multidrug-resistant virus, the person will be
considered eligible to participate in the study. During the baseline
visit, all participants will receive a phenotypic test. Participants
will then be assigned at random to start a new regimen or to stop taking
all antiretrovirals for up to four months before starting a new treatment
regimen. The first 150 participants will have blood samples taken at
weeks 1 and 2 for viral load testing. The study will last for two years,
with required clinic visits for all participants. In addition to evidence
of multidrug resistance by genotypic testing, eligible participants
must have a viral load above 10,000 copies/mL. Exclusion criteria include
pregnancy or breast-feeding, active OIs that require treatment, use
of IL-2 within four months prior to genotypic testing and any use between
that date and study entry, and any vaccinations within 14 days of genotypic
testing. Study locations include Atlanta (404-876-2317), Brookline (888-253-2712),
Chicago (773-244-5800), Denver (303-436-7195), Farmington (860-679-4745),
New Orleans (504-584-1971), New York (212-939-2917), and Portland (503-229-8428).
(CPCRA 064)
This randomized, double-blinded, placebo-controlled study will determine whether rHGH (genetically engineered human growth hormone) reduces the amount of abnormal fat accumulation in persons with HIV-associated adipose redistribution syndrome (HARS, or "lipodystrophy"). rHGH is normally used to treat HIV-related wasting. Two hundred participants will be enrolled to randomly receive either rHGH or placebo (inactive substance), both given as an injection under the skin (preferably at bedtime) either daily or every other day. The size of several different types of fat deposits (e.g., in the breast/chest region, under the skin of the upper back, and within the abdomen) will be measured by x-ray-based body scanning (CT and DEXA scans) as well as anthropometry (using a tape measure) at study entry, week 12, and week 24. Additional laboratory tests will be done, and a quality of life questionnaire will be completed by study participants. The study will last 24 weeks; after week 24, subjects will be allowed to participate in a long-term extension study. Eligible participants must have evidence of excess abdominal fat accumulation and agree to remain on antiretroviral therapy throughout the trial. Study sites include Atlanta (404-876-2317), Birmingham (205-975-7925), Clearwater (727-466-0078 ext. 228), New York (212-523-3202), San Francisco (415-750-2005 or 415-476-9296), and St. Paul (651-221-3589). (22388)
This prospective, placebo-controlled study will determine the safety and effectiveness of testosterone gel in reducing abdominal fat in men. All participants will be assigned at random to receive testosterone gel or placebo. Participants will apply the gel to their shoulders, arms, or stomachs, and receive physical exams and blood tests every six weeks. Questionnaires, body measurements, rectal exams, additional blood tests, and CT (computed tomography) and DEXA (body composition) scans will be done every 12 weeks. After 24 weeks, all participants will be offered testosterone gel for another 24 weeks. Eligible participants must be male, have a viral load below 10,000 copies/mL, and be taking stable (unchanged) antiretroviral treatment for at least 12 weeks prior to study entry, with plans to continue the same regimen for at least another 24 weeks. Exclusion criteria include use of testosterone, anabolic steroids, appetite stimulants, DHEA, growth hormone or other anabolic agents within 12 weeks of study entry, and use of hydroxyurea within 30 days of study entry. The study is being offered in San Francisco (415-514-0550). (A5079)
This prospective study will compare the safety and effectiveness of fenofibrate and pravastatin as treatments for abnormally elevated lipid (fat) levels in the blood. All participants will be assigned at random to take fenofibrate or pravastatin daily for 48 weeks, in addition to their established antiretroviral regimen. After 12 weeks, participants who have not benefited from either drug will take a combination of both drugs for the remainder of the study. Eligible participants must have a triglyceride level of at least 200 mg/dL and a low-density lipoprotein (LDL, or "bad" cholesterol) level of at least 130 mg/dL after 8–12 hours of fasting. They must also be on a lipid-lowering diet and exercise program for at least 30 days before screening for study entry. Exclusion criteria include history of heart disease, uncontrolled high blood pressure, liver or gall bladder disease, diabetes, use of any lipid-lowering drug for over 24 weeks, and pregnancy or breast-feeding. Study locations include Atlanta (404-616-6333), Boston (617-732-5635), Buffalo (716-898-3933), Galveston (409-747-0241), Honolulu (808-737-2751), Los Angeles (323-343-8288), Miami (305-243-3838), New York (212-263-8707), San Diego (619-543-8080), and San Francisco (415-514-0550). (A5087)
This open-label study will determine the safety and effectiveness of FK463, an experimental treatment for invasive aspergillosis, a life-threatening infection caused by the fungus Aspergillus. All participants will receive FK463 by one-hour intravenous infusion for at least seven consecutive days and up to a maximum of 90 days, depending on individual response. The dose of FK463 may be increased during the study, which will last indefinitely, with required weekly clinic visits. Eligible participants must have proven or probable invasive infections due to Aspergillus. All CD4 cell ranges will be considered. The study is being offered in Chicago (312-572-4545) and San Francisco (415-600-6660). (98-0-046)
This open-label study will evaluate the effectiveness of an oral formulation of SCH 56592, an experimental treatment for oral and/or esophageal candidiasis (thrush). All participants will take SCH 56592 as a liquid that is swished around in the mouth and then swallowed. The drug will be taken twice a day for the first three days, followed by once a day for 25 days. The study will last five months, with required weekly clinic visits for the first five weeks. Eligible participants must have evidence of candidiasis in the mouth or esophagus at study entry. Exclusion criteria include pregnancy, breast-feeding, and initial use of PI-based treatment within 30 days of study entry. Study locations include Atlanta (404-616-6333), Chicago (312-942-5865), Dallas (214-590-2503), Indianapolis (317-274-8456), and Washington, DC (202-745-0201). (C97-330)
This study will measure the effects of efavirenz on quantity and quality of sleep in persons who are starting a new antiretroviral regimen that includes efavirenz. All participants will receive a formal evaluation with a sleep specialist at enrollment, followed by three separate evaluations at baseline (before starting efavirenz), within 24 hours of starting efavirenz, and after four to six weeks of treatment. Participants will also keep a sleep diary and undergo a formal overnight inpatient evaluation. The study will last four to six weeks and is being offered in Boston (617-732-5500 ext. 2025).
This study will evaluate how HIV positive women process HAART during pregnancy. All participants will spend one eight-hour day per trimester at the clinic for multiple blood tests that require the use of a catheter to reduce multiple needlesticks. Eligible participants must agree to remain in the study for the duration of their pregnancy. Exclusion criteria include a history of life-threatening events associated with antiretroviral treatment. The study is being offered in San Francisco (415-476-6870).
This open-label
study will compare fat redistribution changes in women taking a triple
NRTI combination regimen or two separate triple combinations containing
two NRTIs and a PI. Eligible participants will be assigned at random
to one of three treatment groups. Group 1 will take d4T, 3TC, and nelfinavir;
Group 2 will take Combivir and nelfinavir; and Group 3 will take Combivir
and abacavir. In addition, participants will receive blood tests and
DEXA scans. The study will last 96 weeks, with required clinic visits
once a month for the first two months. Eligible participants must have
a CD4 cell count above 50 cells/mm3. Exclusion criteria include pregnancy
or breast-feeding, active OIs that require treatment, treatment for
acute hepatitis or chronic active hepatitis, more than one week’s prior
use of 3TC or a PI, more than four weeks’ prior use of an NRTI, and
any prior use of an NNRTI. Study locations include Atlanta (404-876-2317),
Boston (617-632-0785), Charlotte (704-355-7266), Chicago (312-942-4810),
Dallas (214-648-9296), Los Angeles (323-295-6571 ext. 3025), Miami (305-695-1300),
New Orleans (504-568-2470), Philadelphia (215-762-3251), and San Juan
(787-723-5945). (ESS 40002)
This study will determine the safety, tolerability, and effectiveness of adding hydroxyurea to an antiretroviral regimen that includes two NRTIs and one NNRTI. All participants must stop their anti-HIV treatments two weeks before study entry. All subjects will then take d4T, ddI, and efavirenz, and be assigned at random to take hydroxyurea at day 1 or week 6. Blood tests will be administered on days 1, 3, 5, and 7. The study will last one year, with clinic visits required every three weeks for the first three months, followed by once a month. Eligible participants must be between 13 and 21 years of age and have a viral load of at least 10,000 copies/mL. Exclusion criteria include pregnancy, prior use of hydroxyurea, active peripheral neuropathy, past severe peripheral neuropathy related to antiretroviral treatment, active retinal ddI toxicity, and any active infections requiring treatment at study entry. The study is being offered in Bethesda (301-402-1391). (NCI 99 C-0118)
This Phase I/II study will evaluate the safety and effectiveness of the HIV ALVAC vaccine in stimulating an immune response when used alone, or in possible combination with another vaccine, in babies born to HIV-infected mothers. The study will also measure the vaccine’s effects on the infants’ immune systems. The mothers will be enrolled in the study at the 37th week of pregnancy or as soon as possible thereafter. Newborns will be assigned at random to receive the ALVAC vaccine or a placebo, administered by injection within 72 hours after birth, and at 1, 2, and 3 months of age. The first two groups of babies will receive only the ALVAC vaccine. When later vaccine products become available, another group of babies will be assigned at random to receive ALVAC plus the new vaccine or placebo. The study will last two years, with a required total of 12 study visits. Eligible mothers must be at least 27 weeks pregnant. Exclusion criteria include use of any investigational drug during pregnancy and a positive hepatitis B antigen test at study entry. Study locations include Baltimore (410-706-8220), the Bronx (718-918-4516), Chicago (312-572-4547), Denver (303-861-6751), Philadelphia (215-662-3253), San Diego (619-543-8080), San Francisco (415-206-8919), Seattle (206-528-5020), Washington, DC (202-877-5811), and Worcester (508-856-1692). (ACTG 326)
Christopher Gortner is the Editor of Spanish BETA.
Page last updated 30 May 2001
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