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The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs
This study has been completed.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001067
  Purpose

To determine drug efficacy and safety in HIV-infected patients treated with zidovudine ( AZT ) versus stavudine ( d4T ) versus both drugs. Also, to compare short- and long-term changes in magnitude of HIV RNA over time.

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.


Condition Intervention Phase
HIV Infections
Drug: Lamivudine
Drug: Stavudine
Drug: Zidovudine
Phase II

MedlinePlus related topics: AIDS AIDS Medicines
Drug Information available for: Zidovudine Lamivudine Stavudine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Randomized Study of the Virologic and Immunologic Effects of Zidovudine Plus Lamivudine (3TC) Versus d4T Versus Zidovudine Plus d4T in HIV-Infected Patients With CD4 Cell Counts Between 300-600/mm3 and No Previous Nucleoside Experience

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 105
Detailed 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).

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001067

Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
United States, Connecticut
Yale Univ / New Haven
New Haven, Connecticut, United States, 065102483
United States, District of Columbia
Howard Univ
Washington, District of Columbia, United States, 20059
United States, Georgia
Emory Univ
Atlanta, Georgia, United States, 30308
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, United States, 212052196
United States, Missouri
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
United States, New York
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Mount Sinai Med Ctr
New York, New York, United States, 10029
Beth Israel Med Ctr
New York, New York, United States, 10003
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 112032098
United States, North Carolina
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
United States, Ohio
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Texas
Univ of Texas Galveston
Galveston, Texas, United States, 775550435
Puerto Rico
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067
Sponsors and Collaborators
Investigators
Study Chair: Havlir D
Study Chair: Pollard R
Study Chair: Richman D
Study Chair: Friedland G
  More Information

Click here for more information about Zidovudine  This link exits the ClinicalTrials.gov site
Click here for more information about Stavudine  This link exits the ClinicalTrials.gov site
Click here for more information about Lamivudine  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: ACTG 298
Study First Received: November 2, 1999
Last Updated: August 25, 2008
ClinicalTrials.gov Identifier: NCT00001067  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination
AIDS-Related Complex
Zidovudine
Stavudine
Lamivudine

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Stavudine
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lamivudine
Zidovudine
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009