Search / Trial NCT00001067

The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs

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

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Drug Therapy, Combination Aids Related Complex Zidovudine Stavudine Lamivudine

Description

Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies, provides an additional therapeutic option. Patients are randomized to receive d4T alone, AZT alone, or both in combination for at least 12 weeks. After week 12, 3TC is added to the combination arm. Treatment continues for up to 48 weeks (was a total of 48 weeks, amended 3/26/96).

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Required:
  • TMP / SMX, aerosolized pentamidine, or dapsone for PCP prophylaxis.
  • Allowed:
  • Atovaquone.
  • IV pentamidine.
  • TMP / SMX.
  • Trimetrexate.
  • Trimethoprim-dapsone.
  • Clindamycin-primaquine.
  • Topical antifungals.
  • Clotrimazole.
  • Ketoconazole.
  • Fluconazole.
  • Amphotericin B.
  • Itraconazole.
  • Rifabutin.
  • Isoniazid.
  • Pyrazinamide.
  • Clofazimine.
  • Clarithromycin.
  • Azithromycin.
  • Ethambutol.
  • Amikacin.
  • Ciprofloxacin.
  • Ofloxacin.
  • Pyrimethamine.
  • Sulfadiazine.
  • Clindamycin.
  • Filgrastim ( G-CSF ).
  • Up to 1000 mg/day acyclovir.
  • Erythropoietin.
  • Antibiotics.
  • Antipyretics.
  • Analgesics.
  • Antiemetics.
  • Rifampin.
  • Concurrent Treatment:
  • Allowed:
  • Local radiation therapy.
  • Patients must have:
  • HIV infection.
  • CD4 count 300 - 600 cells/mm3.
  • NO history of AIDS.
  • NO active opportunistic infection.
  • NO prior nucleoside therapy.
  • Life expectancy at least 2 years.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Serious underlying medical condition other than HIV such that life expectancy is less than 2 years.
  • Malignancy requiring systemic cytotoxic chemotherapy.
  • Active grade 2 or worse peripheral neuropathy.
  • Concurrent Medication:
  • Excluded:
  • Antiretrovirals other than study drugs.
  • Systemic cytotoxic chemotherapy.
  • Foscarnet.
  • Patients with the following prior conditions are excluded:
  • Chronic diarrhea defined as three or more stools per day for 15 days, within 30 days prior to study entry.
  • Unexplained temperature >= 38.5 C for any 7 days within 30 days prior to study entry.
  • Active participation in other experimental therapy within 30 days prior to study entry.
  • Prior Medication:
  • Excluded:
  • Prior nucleoside antiretrovirals of 1 week or longer duration.
  • Any antiretroviral within 90 days prior to study entry.
  • Non-nucleoside reverse transcriptase inhibitors and protease inhibitors within 30 days prior to study entry.
  • Biologic response modifiers such as IL-2 and interferon within 30 days prior to study entry.

Attachments

readout_NCT00001067_2023-12-10.pdf

4.5 MB

NCT00001067_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

Birmingham, Alabama, United States

Palo Alto, California, United States

San Diego, California, United States

Washington, District Of Columbia, United States

Baltimore, Maryland, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

New York, New York, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Columbus, Ohio, United States

San Juan, , Puerto Rico

Atlanta, Georgia, 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

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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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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