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3TC (Lamivudine; GR109714X) Open-Label Program



3TC (Lamivudine; GR109714X) Open-Label Program

For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 3 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Kern - McNeill International
Morristown,  New Jersey,  07960
United States
 


Additional Information:
Study ID Numbers:  129D;  NUCA 3004
Study Start Date: 
Record last reviewed: November 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002108

Other Hiv Infections Studies:
1. The Healthy Life Choices Project in HIV-Positive Patients

2. Directly Observed Therapy in HIV Infected Adolescent Focus Groups

3. Effects of Potent Antiretroviral Therapy on Kaposi's Sarcoma

4. The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment

5. A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children

Related Studies:

Other HIV Infections Clinical Trials
Other New Jersey Clinical Trials
Other Morristown Clinical Trials

3TC (Lamivudine; GR109714X) Open-Label Program
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