Back to results3TC (Lamivudine; GR109714X) Open-Label Program
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lamivudine
Zidovudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine
Eligibility Criteria
Patients must: Have progressive, symptomatic HIV disease. Have a mean CD4 count <= 99 cells/mm3 for adults and <= 300 cells/mm3 for children (original design was CD4 count <= 300 cells/mm3 for both adults and children). Be unable to participate in a controlled trial. Be refractory to or unable to tolerate other therapies. Be able to attend clinic on a monthly schedule. Have consent of parent or guardian if under the age of consent. NOTE: If a pregnant or breast-feeding woman requests enrollment, her physician should contact Glaxo staff directly to discuss the case. Practice of unsafe sex.
Sites / Locations
- Kern - McNeill International
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002108
Brief Title
3TC (Lamivudine; GR109714X) Open-Label Program
Official Title
3TC (Lamivudine; GR109714X) Open-Label Program
Study Type
Interventional
2. Study Status
Record Verification Date
November 1995
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Glaxo Wellcome
4. Oversight
5. Study Description
Brief Summary
To make lamivudine (3TC) available to patients with progressive, symptomatic HIV disease who cannot participate in a controlled clinical trial and who are refractory or unable to tolerate other therapies. To collect data pertaining to the safety of 3TC at two dose levels. To evaluate the effect of 3TC on markers of hepatitis B in co-infected patients at five to ten selected sites.
Detailed Description
Patients 12 years and older are randomized to receive one of two doses of 3TC for a duration determined by the patient's physician or until termination of the program. Patients < 12 years receive a lower dose of 3TC. Patients are followed monthly. For selected sites only, serum samples are collected every 3 months from patients identified as HBsAg positive.
PER 02/28/95 AMENDMENT: Patients enrolled prior to 3/1/95 may remain on their assigned monotherapy dose or change to combination therapy with 3TC and zidovudine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients must:
Have progressive, symptomatic HIV disease.
Have a mean CD4 count <= 99 cells/mm3 for adults and <= 300 cells/mm3 for children (original design was CD4 count <= 300 cells/mm3 for both adults and children).
Be unable to participate in a controlled trial.
Be refractory to or unable to tolerate other therapies.
Be able to attend clinic on a monthly schedule.
Have consent of parent or guardian if under the age of consent.
NOTE:
If a pregnant or breast-feeding woman requests enrollment, her physician should contact Glaxo staff directly to discuss the case.
Practice of unsafe sex.
Facility Information:
Facility Name
Kern - McNeill International
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Pluda J, Cooley T, Montaner J, McCaffrey R, Wainberg M, Yarchoan R. Phase I/II study of 3TC (GR109714X) in adults with ARC or AIDS. Int Conf AIDS. 1993 Jun 6-11;9(1):69 (abstract no WS-B26-2)
Results Reference
background
Learn more about this trial
3TC (Lamivudine; GR109714X) Open-Label Program
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