3TC (Lamivudine; GR109714X) Open-Label Program

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Lamivudine; Zidovudine

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.