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Open Clinical Trials for HIV/AIDS Treatments

Winter 2002

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 at http://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) -- a clearinghouse of trials relating to all health conditions; it can be found at http://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 800-TRIALS-A (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 provided in parentheses at the end of each listing.


Antiretroviral Therapy


T-20 (Pentafuside)

This open-label study will evaluate the safety of T-20, an experimental fusion inhibitor, and will provide T-20 access, prior to market approval, to persons with advanced HIV disease. Eligible participants must be at least 16 years of age, have a viral load greater than 10,000 copies/mL, and have a CD4 cell count less than 50 cells/mm3. Due to the limited supply of T-20, not all eligible participants will be selected. The drug will be available to 168 persons and there will be only three participants at each study location. First priority will be given to persons who have had an AIDS-defining condition (e.g., an opportunistic illness [OI]) and a CD4 cell count below 50 cells/mm3 while on highly active antiretroviral therapy (HAART) within the preceding 90 days. Study locations will be selected according to applications submitted by physicians; persons who wish to participate in this study should contact their medical providers. Physicians who wish to enroll their patients should call 800-526-6367 for more information. (T20-305)


Tipranavir, Ritonavir (Norvir), Saquinavir (Fortovase)

This open-label, randomized study will compare different combinations of tipranavir (an experimental protease inhibitor [PI]) for safety and effectiveness in participants who did not have success with their first PI combination. All participants will take two new nucleoside reverse transcriptase inhibitors (NRTIs), such as AZT (Retrovir), ddI (Videx), or ddC (Hivid). In addition, participants will be assigned by chance to receive one of two doses of tipranavir either alone or combined with ritonavir or saquinavir plus ritonavir. All medications are pills taken by mouth. After two screening visits, participants will have study visits every two weeks during the first month, then once a month for six months. Participants who show an adequate response to treatments will be permitted to continue treatment for an additional 24-week extension study. Eligible participants must have at least six months use of current PI therapy; be experiencing lack of success with present combination therapy containing indinavir (Crixivan), nelfinavir (Viracept), or amprenavir (Agenerase) plus two NRTIs; and have at least two NRTI options available. In addition, participants must be at least 13 years of age, have a CD4 cell count of more than 50 cells/mm3, and have a viral load of more than 5,000 copies/mL. Exclusion criteria include active OIs; prior use of saquinavir, ritonavir, or tipranavir; pregnancy or breast-feeding; use of interferons, interleukins, or HIV vaccines; and active alcohol or substance abuse. Study locations include Columbus (614-293-8112), Los Angeles (310-657-9353), Miami (305-243-5621), Milwaukee (414-225-1548), Oklahoma City (405-271-8001), and Washington, DC (202-745-6111). (BI1182-4/M3342-0016)

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Atazanavir, Saquinavir, Ritonavir

This Phase II study will compare the safety and effectiveness of atazanavir (also known as BMS-232632) or ritonavir in a double-PI combination that includes saquinavir. Participants will be assigned randomly to one of three groups. Groups 1 and 2 will take atazanavir in different doses plus saquinavir and two other anti-HIV drugs. Group 3 will take ritonavir plus saquinavir and two other anti-HIV drugs. The study will last 48 weeks. Eligible participants must have a viral load of at least 2,000 copies/mL, a CD4 cell count of at least 100 cells/mm3, or a CD4 cell count of at least 75 cells/mm3 without a prior history of AIDS-defining illnesses, and be available for 48 weeks of follow-up. Participants also must have been taking an anti-HIV drug combination that includes a PI or NNRTI for a minimum of 24 weeks and be experiencing an increase in viral load. Exclusion criteria include severe diarrhea within 30 days of study entry, history of pancreatitis, active peripheral neuropathy, or substance abuse. Study locations include Birmingham (205-458-8700), Cleveland (216-844-8051), Dallas (214-648-2788), Decatur (404-297-9755), Houston (713-830-3013), New Haven (203-785-6939), and Oakland (510-986-1900). (AI424-009)


Interleukin-2 (IL-2)

This Phase III, randomized, open-label study will assess the clinical benefit of IL-2 as a complement to standard antiretroviral therapy. In this international study, participants will be assigned randomly to one of two groups. Group 1 will receive IL-2 by subcutaneous injection. Group 2 will not receive the study drug to see whether or not IL-2 has any effect on the progression of HIV disease. The study will last approximately six years. Eligible participants must be at least 18 years of age, have access to antiretroviral treatment, and have a CD4 cell count of at least 300 cells/mm3. Exclusion criteria include prior IL-2 therapy, any malignancy (cancer) requiring chemotherapy, evidence of active clinical disease, central nervous system (CNS) abnormalities, autoimmune/inflammatory diseases with potentially life-threatening complications, use of certain systemic agents, pregnancy, or breastfeeding. Study locations include Berkeley (415-476-9554), Chicago (312-569-7183), Houston (713-830-3011), Los Angeles (310-478-3711), Miami (305-324-3267), Minneapolis (612-863-5336), Portsmouth (757-953-6983), and San Francisco (415-476-9554). (ESPRIT)


GW433908

This Phase III, randomized, open-label study will compare the safety and effectiveness of two different doses of GW433908 with ritonavir vs lopinavir/ritonavir (Kaletra). GW433908 is the prodrug of amprenavir (a PI drug currently marketed as Agenerase), which means that GW433908 is converted into amprenavir in the body. Study participants will be assigned randomly to one of three groups. The first group will receive GW433908 (700 mg twice daily) with ritonavir (100 mg twice daily). The second group will receive GW433908 (1,400 mg twice daily) with ritonavir (200 mg once daily). The third group will receive Kaletra (400 mg lopinavir with 100 mg ritonavir) twice daily. All study participants also will take two NRTIs with the above combinations. Computed tomography (CT) scans will be taken on day 1 and at weeks 24 and 48 to observe any fat distribution changes. The study will last 48 weeks. Eligible participants must be at least 13 years of age, currently be taking anti-HIV therapy that includes a PI, have a viral load of at least 1,000 copies/mL, and agree to the use of adequate barrier methods of birth control for the duration of the study. Exclusion criteria include pregnancy, breast-feeding, prior use of amprenavir or Kaletra for more than one week, prior use of more than two PIs, history of hepatitis or pancreatitis in the preceding six months, treatment with an HIV vaccine in the preceding three months, use of certain medications, and current use of alcohol or illicit drugs. Study locations include Newport Beach (949-646-1111), San Francisco (415-292-5477), Somerville (908-725-1551), and Voorhees (856-566-3192). (APV30003)


Structured Treatment Interruption (STI)


Multidrug-Resistant Virus and STI

This study will evaluate the effectiveness of immediately changing to a new antiretroviral regimen or starting a new treatment regimen after first 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 then will be assigned at random to start a new regimen or to stop taking all antiretroviral drugs 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 having 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 the Bronx (718-901-6346), Chicago (773-244-5800), Detroit (313-966-0267), Houston (713-830-3050), New Orleans (504-584-1971), New York (212-939-2917), Portland (503-229-8428), and San Francisco (415-476-9554). (CPCRA 064)


Other Conditions


Cytomegalovirus (CMV): Valganciclovir (Valcyte)

This Phase III, randomized, double-blind trial will evaluate the safety and effectiveness of valganciclovir in preventing organ damage due to CMV. The study is divided into three steps. Step 1 is a screening phase in which eligible participants will have study visits every eight weeks and be tested for CMV DNA (genetic material). Study participants with a positive CMV DNA result (and no history of active CMV disease) will then move on to the next step. In step 2, participants will be assigned randomly to take valganciclovir or placebo (neither participants nor their physicians will know which they are receiving until study conclusion). Both valganciclovir and placebo will be administered orally in pill form. Participants in step 2 will receive physical and eye examinations every eight weeks. They will also have blood tests at weeks 2, 4, 6, 8, 10, 12, and every four weeks thereafter. Those participants that develop organ damage due to CMV will enter step 3. Participants in step 3 who develop CMV retinitis will receive genuine valganciclovir (no placebo). Participants who develop CMV in other organs will not be permitted to take valganciclovir, and their physicians will determine the best treatment for CMV disease. Participants receiving valganciclovir in step 3 will have blood tests at weeks 2, 4, 6, 8, 10, 12, and every four weeks thereafter. In addition, at weeks 2, 4, and every twelve weeks thereafter, participants will have eye examinations and photographs taken of the eye. The study will last about three years. Eligible participants must be at least 13 years of age, have a CD4 cell count below 100 cells/mm3, have a viral load above 400 copies/mL, be CMV antibody positive, have been taking HAART continuously for at least three months, or have not received HAART and have planned not to start HAART until three months after study entry. Exclusion criteria include previous CMV disease of any organ, use of any anti-CMV medications within eight weeks of study entry, pregnancy, or breast-feeding. Study locations include Birmingham (205-975-7925), Chicago (312-695-5012), Los Angeles (323-343-8288), Nashville (615-467-0154), San Diego (619-543-8080), San Francisco (415-514-0550), and Washington, DC (202-687-5378). (ACTG 5030)


Hepatitis C Virus (HCV): Ribavirin, Interferon Alpha-2a, Peginterferon Alpha-2a (Pegasys)

This Phase III, randomized, partially blinded, three-arm study will evaluate the safety and effectiveness of different combinations of peginterferon alpha-2a, ribavirin, and interferon alpha-2a in persons coinfected with HIV and HCV. Participants will be assigned randomly to one of three groups. The first group will take peginterferon alpha-2a plus ribavirin placebo pills. The second group will take peginterferon alpha-2a by injection once a week plus ribavirin. The third group will take interferon alpha-2a by injection three times a week plus ribavirin. Treatment will last 48 weeks, and study visits will take place every two weeks for the first two months, then at week 12, then every six weeks. There will be three study visits after treatment has ended. Eligible participants must be at least 18 years of age, have a CD4 cell count of at least 200 cells/mm3 with any HIV viral load or a CD4 cell range between 100 and 199 cells/mm3 and a viral load of less than 5,000 copies/mL, and have detectable HCV. In addition, participants taking HAART must be on stable (unchanged) therapy. Participants who have not been taking HAART for at least eight weeks prior to study entry must be willing to delay HAART for at least six weeks. Exclusion criteria include pregnancy, breast-feeding, male partners of pregnant women, prior use of interferon or ribavirin, active OIs or malignancies requiring systemic treatment, use of any investigational drugs within six weeks of the study, past or current evidence of chronic liver disease other than HCV, severe seizure disorders, active alcohol and/or substance use, or use of any chemotherapy or immunomodulators within six months of study entry. Study locations include Albany (518-262-6330), Boston (617-636-5311), Galveston (409-747-0241), Salt Lake City (801-581-6791), San Diego (619-543-8080), and San Francisco (415-353-0800). (NR15961)


Pregnant Women and Infants


Indinavir (Crixivan), 3TC (Epivir), AZT

This Phase I trial will evaluate the safety, tolerability, and metabolism of oral indinavir coadministered with 3TC and AZT in HIV-positive pregnant women during gestation and postpartum (after birth), and in their infants postpartum. Pregnant women will receive indinavir, 3TC, and AZT from the time they enter the study (first or second trimester) until 12 weeks after delivery. Women will receive physical and pelvic examinations and will have blood drawn approximately every two weeks before birth and at weeks 6 and 12 after delivery. Women will also receive ultrasound examinations during pregnancy. Infants will receive 3TC and AZT for six weeks. They will have five clinic visits (day 8, weeks 3 and 6, and months 3 and 6) for physical examinations and blood tests. Women will be studied for 24-38 weeks, and infants will be studied for 24 weeks. Eligible women include those who are HIV positive and at least 13 years of age (those under 18 years of age must have parental consent). Women must be in their first or second trimester (pregnant for 14-28 weeks) and have a normal ultrasound examination during initial screening. Exclusion criteria include women who are unable to take 3TC or AZT, any active OI or bacterial infection at study entry, chronic diarrhea, epilepsy, or cancer. Also, women cannot be pregnant with more than two children (e.g., triplets); have risk factors for problems with pregnancy; have any immediate life-threatening illness, severe anemia, or illness for which they require blood products; or have a history of chronic liver or kidney disease. Participating women cannot breast-feed. Study locations include Boston (617-355-8198), the Bronx (718-918-4516), Houston (832-824-2583), and New York (212-305-7222). (ACTG 358)


Abacavir (Ziagen), AZT

This Phase I study will evaluate the safety, tolerability, and metabolism of single-dose and multiple-dose abacavir in HIV-exposed infants receiving standard postnatal AZT. The study will be divided into two parts. Infants in part 1 will be grouped according to age and will receive a single oral dose of abacavir. If serious toxicities do not occur, babies will receive an increased dose of abacavir. Part 2 is a multiple-dose study that will examine a six-week dosing schedule of abacavir for infants 0-48 hours of age. The doses for each age group as identified in part 1 will be applied to infants in part 2 until they reach 42 days of age. All babies in parts 1 and 2 will continue to receive standard AZT therapy throughout the trial. Blood samples will be taken at certain time points to determine safety, tolerance, and metabolism. Eligible babies include infants between 0 and 48 hours of age, between 3 and 7 days of age, or between 21 and 28 days of age. Participating infants must not have any serious infections requiring treatment during the study period, must be receiving AZT monotherapy, must have the ability to tolerate oral feeding, and must be born to HIV-positive mothers whose pregnancy lasted at least 37 weeks. Exclusion criteria include infants who have a major congenital abnormality, have experienced serious toxicity at the time of study entry, or previous enrollment in part 1. Study locations include the Bronx (718-918-4602), Charleston (803-792-5311), Chicago (312-413-8089), Jacksonville (904-549-5331), Los Angeles (310-206-6369), San Juan (787-759-9595), and Syracuse (315-464-6331). (ACTG 321)


Alternative Treatment


Distant Healing (DH)

This randomized, double-blinded study will investigate DH by nurses and healers as an additional intervention along with antiretroviral treatment. One hundred and fifty participants will be divided randomly into ten groups of 15 people. In each group, five participants will receive DH attempts by professional healers, five participants will receive DH attempts by nurses, and five participants will receive no additional intervention. Participants will be required to provide a personal photograph, make three one-hour study visits, and have blood drawn. Eligible participants must be between the ages of 18 and 65, be using anti-HIV therapy, have a history of a CD4 cell count below 200 cells/mm3, and speak and read English. Exclusion criteria include inability or unwillingness to fill out questionnaires, or a history of non-HIV-related life-threatening diseases. The study will be conducted in San Francisco (415-502-5705).

Blanca Rivas is the editorial assistant of BETA.




  
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This article was provided by San Francisco AIDS Foundation. It is a part of the publication Bulletin of Experimental Treatments for AIDS. Visit San Francisco AIDS Foundation's Web site to find out more about their activities, publications and services.
 

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