The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs
NCT ID: NCT00001067
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
105 participants
INTERVENTIONAL
1997-11-30
Brief Summary
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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.
Detailed Description
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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).
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Lamivudine
Stavudine
Zidovudine
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Havlir D
Role: STUDY_CHAIR
Pollard R
Role: STUDY_CHAIR
Richman D
Role: STUDY_CHAIR
Friedland G
Role: STUDY_CHAIR
Locations
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Alabama Therapeutics CRS
Birmingham, Alabama, United States
Stanford CRS
Palo Alto, California, United States
Ucsd, Avrc Crs
San Diego, California, United States
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., District of Columbia, United States
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
Washington U CRS
St Louis, Missouri, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
Puerto Rico-AIDS CRS
San Juan, , Puerto Rico
Countries
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References
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Cadman J. 2, 4, 6, 8, who's afraid to phosphorylate? GMHC Treat Issues. 1998 Feb;12(2):6-8.
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. doi: 10.1089/088922202760072311.
Other Identifiers
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11274
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 298
Identifier Type: -
Identifier Source: org_study_id