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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00001068
Other study ID # ACTG 303
Secondary ID 11278
Status Completed
Phase Phase 2
First received
Last updated
Est. completion date October 1998

Study information

Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the influence of virus load, CD4 count, biologic phenotype, and presence of symptomatic disease on the response of HIV-infected patients to a new therapeutic regimen. PER AMENDMENT 8/27/96: To extend the availability of currently assigned ACTG 303 treatment for 6 months.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date October 1998
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria Patients must have: - Prior participation on protocol ACTG 175. PER AMENDMENT 8/27/96: - Patients must be on study/on treatment at the time the protocol study treatment is extended.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lamivudine


Locations

Country Name City State
Puerto Rico Puerto Rico-AIDS CRS San Juan
Tanzania Mbeya Med. Research Program, Mbeya Referral Hosp. CRS Mbeya
United States Emory Univ. Hemophilia Program Office Atlanta Georgia
United States University of Colorado Hospital CRS Aurora Colorado
United States Johns Hopkins Adult AIDS CRS Baltimore Maryland
United States Alabama Therapeutics CRS Birmingham Alabama
United States Beth Israel Deaconess - East Campus A0102 CRS Boston Massachusetts
United States Beth Israel Deaconess Med. Ctr., ACTG CRS Boston Massachusetts
United States Bmc Actg Crs Boston Massachusetts
United States Massachusetts General Hospital ACTG CRS Boston Massachusetts
United States SUNY - Buffalo, Erie County Medical Ctr. Buffalo New York
United States Unc Aids Crs Chapel Hill North Carolina
United States Carolinas HealthCare System, Carolinas Med. Ctr. Charlotte North Carolina
United States Cook County Hosp. CORE Ctr. Chicago Illinois
United States Northwestern University CRS Chicago Illinois
United States Rush Univ. Med. Ctr. ACTG CRS Chicago Illinois
United States Univ. of Cincinnati CRS Cincinnati Ohio
United States Case CRS Cleveland Ohio
United States The Ohio State Univ. AIDS CRS Columbus Ohio
United States Regional Center for Infectious Disease, Wendover Medical Center CRS Greensboro North Carolina
United States Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis Indiana
United States UCLA CARE Center CRS Los Angeles California
United States USC CRS Los Angeles California
United States Univ. of Miami AIDS CRS Miami Florida
United States University of Minnesota, ACTU Minneapolis Minnesota
United States Tulane Hemophilia Treatment Ctr. New Orleans Louisiana
United States Beth Israel Med. Ctr. (Mt. Sinai) New York New York
United States Cornell University A2201 New York New York
United States NY Univ. HIV/AIDS CRS New York New York
United States Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. Omaha Nebraska
United States Stanford CRS Palo Alto California
United States Hosp. of the Univ. of Pennsylvania CRS Philadelphia Pennsylvania
United States Univ. of Rochester ACTG CRS Rochester New York
United States St. Louis ConnectCare, Infectious Diseases Clinic Saint Louis Missouri
United States Washington U CRS Saint Louis Missouri
United States Ucsd, Avrc Crs San Diego California
United States Ucsf Aids Crs San Francisco California
United States Santa Clara Valley Med. Ctr. San Jose California
United States University of Washington AIDS CRS Seattle Washington
United States San Mateo County AIDS Program Stanford California
United States Harbor-UCLA Med. Ctr. CRS Torrance California

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico,  Tanzania, 

References & Publications (1)

Albrecht MA, Hughes MD, Liou SH, Katzenstein DA, Murphy R, Balfour HH, Para MF, Valdez H, Hammer SM; ACTG 303 Study Team. Effect of lamivudine in HIV-infected persons with prior exposure to zidovudine/didanosine or zidovudine/zalcitabine. AIDS Res Hum Retroviruses. 2000 Sep 20;16(14):1337-44. — View Citation

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