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Home > "T" Clinical Trials Conditions > The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More than 12 Weeks  The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More than 12 Weeks
The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More than 12 Weeks
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb
Synopsis: To compare the effect of stavudine (d4T) alone or with zidovudine (AZT) versus didanosine (ddI) alone or with AZT on CD4 counts, HIV RNA levels, and viral load in HIV-infected patients [AS PER AMENDMENT 3/21/97: To compare the effects of d4T alone versus ddI alone versus AZT plus ddI]. To compare the safety of d4T/AZT. AS PER AMENDMENT 3/21/97: To evaluate the pharmacokinetic interactions of AZT and d4T both at an extracellular and intracellular level. Although AZT and ddI can delay the advancement of HIV disease, the benefit of either of these drugs has proven to be only temporary. d4T, a new nucleoside analog with a favorable toxicity profile and demonstrated activity against HIV, offers an additional therapeutic option. It is reasonably assumed that the benefit of an antiretroviral agent in terms of delaying clinical disease progression is directly related to its ability to achieve and sustain viral suppression; thus, this study measures effects on viral load and CD4 count.
Details: Although AZT and ddI can delay the advancement of HIV disease, the benefit of either of these drugs has proven to be only temporary. d4T, a new nucleoside analog with a favorable toxicity profile and demonstrated activity against HIV, offers an additional therapeutic option. It is reasonably assumed that the benefit of an antiretroviral agent in terms of delaying clinical disease progression is directly related to its ability to achieve and sustain viral suppression; thus, this study measures effects on viral load and CD4 count. Patients are randomized in a blinded fashion to receive AZT or placebo in combination with open-label d4T or ddI for up to 48 weeks. AS PER AMENDMENT 3/21/97: The study is now composed of three arms: open-label d4T versus open-label ddI plus blinded AZT placebo versus blinded AZT plus open-label ddI. Patients originally assigned to the d4T + AZT arm, which was closed 10/96, will be given the option of discontinuing AZT and remaining on d4T monotherapy or discontinuing all study drugs. In addition, all study participants will be asked to participate in a pharmacology substudy.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required for patients whose CD4 count falls below 200 cells/mm3: - PCP prophylaxis with TMP/SMX, aerosolized pentamidine, or dapsone. Allowed: - Atovaquone, IV pentamidine, trimethoprim-dapsone, clindamycin-primaquine, trimetrexate, or TMP/SMX for acute PCP. - Topical antifungals, clotrimazole, ketoconazole, fluconazole, and amphotericin B for mucosal and esophageal candidiasis. - Itraconazole. - Amphotericin B. - Rifabutin. - Isoniazid. - Pyrazinamide. - Clofazimine. - Clarithromycin. - Azithromycin. - Ethambutol. - Amikacin. - Ciprofloxacin. - Ofloxacin. - Pyrimethamine. - Sulfadiazine. - Clindamycin. - Ganciclovir. - G-CSF. - Acyclovir (up to 1000 mg/day). - Erythropoietin. - Antibiotics for bacterial infections. - Antipyretics. - Analgesics. - Antiemetics. - Rifampin. Concurrent Treatment: Allowed: - Local radiation therapy. Patients must have: - HIV infection. - CD4 count 300-600 cells/mm3. - More than 12 weeks (was 24 weeks, AMENDED 3/31/96) of total prior AZT ( > 500 mg/day without serious adverse event). Subjects must be actively taking ZDV for at least 4 continuous weeks up to the time of study entry. - No prior or current history of AIDS. - No active opportunistic infection. - Life expectancy of at least 2 years. - Consent of patient and parent or guardian if less than 18 years of age. NOTE: - Protocol is approved for prisoner enrollment. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Malignancy requiring systemic cytotoxic chemotherapy. - Serious underlying medical condition other than HIV that would reduce life expectancy to < 2 years. Concurrent Medication: Excluded: - Antiretrovirals other than study drugs. - Foscarnet. Patients with the following prior conditions are excluded: - Unexplained temperature >= 38.5 C for 7 days or chronic diarrhea (>= three stools daily) for 15 days, if occurring within 30 days prior to study entry. - History of acute or chronic pancreatitis. - History of grade 2 or higher peripheral neuropathy. - History of grade 3 or worse intolerance to 500-600 mg/day AZT. Prior Medication: Excluded: (within 30 days prior to study entry) - Prior ddI, ddC, 3TC or d4T (more than 2 weeks total). - Non-nucleoside reverse transcriptase inhibitor or protease inhibitor. - Biologic response modifiers such as interferon and IL-2. - Other experimental therapy.
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
HavlirD, Study Chair,
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Illinois Masonic Med Ctr
Chicago, Illinois, 606575147
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, 77030
United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Comprehensive Health Care Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Tulane Med Ctr Hosp
New Orleans, Louisiana, 70112
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Great Lakes Hemophilia Foundation
Wauwatosa, Wisconsin, 532130127
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Univ of Washington
Seattle, Washington, 981224304
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Children's Hosp of Los Angeles
Los Angeles, California, 90027
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Rose Med Ctr
Denver, Colorado, 80262
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, 11203
United States
Hennepin County Med Clinic
Minneapolis, Minnesota, 55415
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Mountain States Reg Hemo Ctr / Univ of Colorado
Denver, Colorado, 80262
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Additional Information:
Study ID Numbers: ACTG 290;
Study Start Date:
Record last reviewed: November 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001063
Other Hiv Infections Studies:
1. A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children
2. Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure
3. Interleukin-2 (IL-2) Treatment for HIV Infected Patients Who Have Interrupted Their Anti-HIV Drug Therapy
4. A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma
5. A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
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The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More than 12 Weeks
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