The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Lamivudine (Drug); Stavudine (Drug); Zidovudine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Havlir D, Study Chair
Pollard R, Study Chair
Richman D, Study Chair
Friedland G, Study Chair
Summary
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.
Clinical Details
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
Study design: Treatment
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
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Univ of Puerto Rico, San Juan 009365067, Puerto Rico
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Univ of California / San Diego Treatment Ctr, San Diego, California 921036325, United States
Stanford Univ Med Ctr, Stanford, California 943055107, United States
Yale Univ / New Haven, New Haven, Connecticut 065102483, United States
Howard Univ, Washington, District of Columbia 20059, United States
Emory Univ, Atlanta, Georgia 30308, United States
Johns Hopkins Hosp, Baltimore, Maryland 21287, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp, Baltimore, Maryland 212052196, United States
St Louis Regional Hosp / St Louis Regional Med Ctr, St. Louis, Missouri 63112, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States
Mount Sinai Med Ctr, New York, New York 10029, United States
Beth Israel Med Ctr, New York, New York 10003, United States
SUNY / Health Sciences Ctr at Brooklyn, Brooklyn, New York 112032098, United States
Univ of North Carolina, Chapel Hill, North Carolina 275997215, United States
Duke Univ Med Ctr, Durham, North Carolina 277103499, United States
Ohio State Univ Hosp Clinic, Columbus, Ohio 432101228, United States
Julio Arroyo, West Columbia, South Carolina 29169, United States
Univ of Texas Galveston, Galveston, Texas 775550435, United States
Additional Information
Click here for more information about Zidovudine Click here for more information about Stavudine Click here for more information about Lamivudine
Related 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.
Last updated: June 23, 2005
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