NCT00001068

Brief 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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Geographic Reach
3 countries

41 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

October 1, 1998

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

Keywords

ZalcitabineDidanosineDrug Therapy, CombinationAIDS-Related ComplexAntiviral AgentsZidovudineLamivudine

Interventions

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

Alabama Therapeutics CRS

Birmingham, Alabama, 35294, United States

Location

USC CRS

Los Angeles, California, 90033, United States

Location

UCLA CARE Center CRS

Los Angeles, California, 90095, United States

Location

Stanford CRS

Palo Alto, California, 94115, United States

Location

Ucsd, Avrc Crs

San Diego, California, United States

Location

Ucsf Aids Crs

San Francisco, California, 94110, United States

Location

Santa Clara Valley Med. Ctr.

San Jose, California, 95128, United States

Location

San Mateo County AIDS Program

Stanford, California, 94305, United States

Location

Harbor-UCLA Med. Ctr. CRS

Torrance, California, 90502, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, 33136, United States

Location

Emory Univ. Hemophilia Program Office

Atlanta, Georgia, 30365, United States

Location

Northwestern University CRS

Chicago, Illinois, 60611, United States

Location

Cook County Hosp. CORE Ctr.

Chicago, Illinois, 60612, United States

Location

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, 60612, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, United States

Location

Tulane Hemophilia Treatment Ctr.

New Orleans, Louisiana, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, 02114, United States

Location

Bmc Actg Crs

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess - East Campus A0102 CRS

Boston, Massachusetts, United States

Location

Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, United States

Location

University of Minnesota, ACTU

Minneapolis, Minnesota, 55455, United States

Location

St. Louis ConnectCare, Infectious Diseases Clinic

St Louis, Missouri, United States

Location

Washington U CRS

St Louis, Missouri, United States

Location

Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.

Omaha, Nebraska, 68198, United States

Location

SUNY - Buffalo, Erie County Medical Ctr.

Buffalo, New York, 14215, United States

Location

Beth Israel Med. Ctr. (Mt. Sinai)

New York, New York, 10003, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Cornell University A2201

New York, New York, 10021, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas HealthCare System, Carolinas Med. Ctr.

Charlotte, North Carolina, 28203, United States

Location

Regional Center for Infectious Disease, Wendover Medical Center CRS

Greensboro, North Carolina, 27401, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 45267, United States

Location

Case CRS

Cleveland, Ohio, 44106, United States

Location

The Ohio State Univ. AIDS CRS

Columbus, Ohio, 43210, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

University of Washington AIDS CRS

Seattle, Washington, 98122, United States

Location

Puerto Rico-AIDS CRS

San Juan, 00936, Puerto Rico

Location

Mbeya Med. Research Program, Mbeya Referral Hosp. CRS

Mbeya, Tanzania

Location

Related 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. doi: 10.1089/08892220050140883.

    PMID: 11018853BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAIDS-Related Complex

Interventions

Lamivudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

October 1, 1998

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations