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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001067
First received: November 2, 1999
Last updated: May 1, 2012
Last verified: May 2012
  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 2

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


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

Estimated Enrollment: 105
Study Completion Date: November 1997
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001067

Locations
United States, Alabama
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
United States, California
Stanford CRS
Palo Alto, California, United States, 94305
Ucsd, Avrc Crs
San Diego, California, United States, 92103
United States, District of Columbia
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington, District of Columbia, United States, 20059
United States, Georgia
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, United States
United States, Maryland
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
United States, Missouri
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States, 63112
Washington U CRS
St. Louis, Missouri, United States, 63110
United States, New York
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States, 10016
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States, 10003
United States, North Carolina
Unc Aids Crs
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States, 43210
Puerto Rico
Puerto Rico-AIDS CRS
San Juan, Puerto Rico
Sponsors and Collaborators
Investigators
Study Chair: Havlir D
Study Chair: Pollard R
Study Chair: Richman D
Study Chair: Friedland G
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001067     History of Changes
Other Study ID Numbers: ACTG 298, 11274
Study First Received: November 2, 1999
Last Updated: May 1, 2012
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lamivudine
Zidovudine
Stavudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Antimetabolites

ClinicalTrials.gov processed this record on September 16, 2014