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

Sponsor:	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

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Zidovudine Lamivudine Stavudine

U.S. FDA Resources

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

Estimated Enrollment:	105
Primary Completion Date:	November 1997 (Final data collection date for primary outcome measure)

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
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 112032098
Mount Sinai Med Ctr
New York, New York, United States, 10029
Beth Israel Med Ctr
New York, New York, United States, 10003
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
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

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:	Havlir D
Study Chair:	Pollard R
Study Chair:	Richman D
Study Chair:	Friedland G

More Information

Additional 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:

Cadman J. 2, 4, 6, 8, who's afraid to phosphorylate? GMHC Treat Issues. 1998 Feb;12(2):6-8. No abstract available.

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)

Pollard RB, Tierney C, Havlir D, Tebas P, Fox L, Smeaton L, Richman D, Friedland GH. A phase II randomized study of the virologic and immunologic effect of zidovudine + stavudine versus stavudine alone and zidovudine + lamivudine in patients with >300 CD4 cells who were antiretroviral naive (ACTG 298). AIDS Res Hum Retroviruses. 2002 Jul 1;18(10):699-704.

ClinicalTrials.gov Identifier:	NCT00001067 History of Changes
Other Study ID Numbers:	ACTG 298
Study First Received:	November 2, 1999
Last Updated:	March 1, 2011
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
Zidovudine
Stavudine

Lamivudine
Anti-HIV Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 13, 2012