3TC (Lamivudine; GR109714X) Open-Label Program

GlaxoSmithKline (GSK)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Zidovudine; Drug: Lamivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002108

129D

NUCA 3004

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.