Search / Trial NCT00001063

The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More Than 12 Weeks

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Didanosine Drug Therapy, Combination Aids Related Complex Zidovudine Stavudine

Description

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 o...

Gender

All

Eligibility 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.

Attachments

readout_NCT00001063_2024-03-02.pdf

4.5 MB

NCT00001063_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

Palo Alto, California, United States

San Diego, California, United States

San Francisco, California, United States

Torrance, California, United States

Aurora, Colorado, United States

Miami, Florida, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Minneapolis, Minnesota, United States

Minneapolis, Minnesota, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Buffalo, New York, United States

Rochester, New York, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Seattle, Washington, United States

San Juan, , Puerto Rico

Washington, District Of Columbia, United States

Brooklyn, New York, United States

San Juan, , Puerto Rico

Jacksonville, Florida, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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