The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More Than 12 Weeks
NCT ID: NCT00001063
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
1997-11-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Stavudine
Zidovudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Havlir D
Role: STUDY_CHAIR
Richman D
Role: STUDY_CHAIR
Pollard R
Role: STUDY_CHAIR
Friedland G
Role: STUDY_CHAIR
Locations
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UCLA CARE Center CRS
Los Angeles, California, United States
Stanford CRS
Palo Alto, California, United States
Ucsd, Avrc Crs
San Diego, California, United States
Ucsf Aids Crs
San Francisco, California, United States
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
Northwestern University CRS
Chicago, Illinois, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States
Weiss Memorial Hosp.
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, United States
Tulane Hemophilia Treatment Ctr.
New Orleans, Louisiana, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States
Bmc Actg Crs
Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States
Hennepin County Med. Ctr., Div. of Infectious Diseases
Minneapolis, Minnesota, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
Washington U CRS
St Louis, Missouri, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
University of Washington AIDS CRS
Seattle, Washington, United States
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Puerto Rico-AIDS CRS
San Juan, , Puerto Rico
Countries
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References
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d4T+AZT--unexpected CD4 drop seen in study. AIDS Treat News. 1996 Dec 20;(No 261):1.
Shaefer M, Hardy WD, Shaker-Irwin L, Williams V, Maude C, Thommes J, Graham N. HIV viral load response in subjects switched from zidovudine (ZDV)-containing to stavudine (D4T)-containing regimens in the Pacific Oaks Population Study (POPS). Int Conf AIDS. 1998;12:57 (abstract no 12228)
Havlir DV, Friedland G, Pollard R, Tierney C, Smeaton L, Fox L, Richman DD. Combination zidovudine (ZDV) and stavudine (d4T) therapy versus other nucleosides: report of two randomized trials (ACTG 290 and 298). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:79 (abstract no 2)
Cadman J. 2, 4, 6, 8, who's afraid to phosphorylate? GMHC Treat Issues. 1998 Feb;12(2):6-8.
Havlir DV, Tierney C, Friedland GH, Pollard RB, Smeaton L, Sommadossi JP, Fox L, Kessler H, Fife KH, Richman DD. In vivo antagonism with zidovudine plus stavudine combination therapy. J Infect Dis. 2000 Jul;182(1):321-5. doi: 10.1086/315683. Epub 2000 Jul 6.
Sommadossi JP, Zhou XJ, Moore J, Havlir DV, Friedland G, Tierney C, Smeaton L, Fox L, Richman D, Pollard R. Impairment of stavudine (d4T) phosphorylation in patients receiving a combination of zidovudine (ZDV) and d4T (ACTG 290). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:79 (abstract no 3)
Other Identifiers
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11266
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 290
Identifier Type: -
Identifier Source: org_study_id