Whitehouse Station,
New Jersey
08889
Purpose:
To compare effects on CD4 counts and serum viral RNA among HIV-seropositive, zidovudine
(AZT)-experienced patients in three treatment arms: indinavir sulfate ( MK-639; Crixivan )
plus AZT plus lamivudine ( 3TC ) versus MK-639 alone versus AZT/3TC.
Study summary:
AZT-experienced patients are randomized to receive MK-639/AZT/3TC or MK-639 alone or
AZT/3TC. Additionally, patients who have received < 6 months of AZT or who are intolerant
but received prior 3TC or who require concomitant rifampin therapy may receive open-label
MK-639.
Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed for all patients:
- Standard prophylaxis for opportunistic infections.
- Continuation of treatment for opportunistic infection.
Allowed for open-label study patients:
- Rifampin.
Patients must have:
- HIV positivity.
- CD4 count <= 50 cells/mm3.
- More than 6 months of prior AZT (blinded study only).
NOTE:
- Patients on the open-label study must have AZT intolerance or have < 6 months of
prior AZT.
Prior Medication:
Required for blinded study patients:
- > 6 months of prior AZT.
Required for open-label study patients:
- < 6 months of prior AZT.
Allowed for open-label study patients:
- Prior 3TC.
Exclusion Criteria
Concurrent Medication:
Excluded in all patients:
- Immunosuppressants.
Excluded in blinded study patients:
- AZT, ddI, ddC, or d4T.
- Rifampin.
Excluded in open-label study patients:
- 3TC.
Prior Medication:
Excluded in all patients:
- Prior protease inhibitors.
- Investigational agents and immunomodulators within 30 days prior to study entry.
- Immunosuppressants within 2 weeks prior to study entry.
Excluded in blinded study patients:
- Any prior 3TC.
- AZT, ddI, ddC, or d4T within 2 weeks prior to study entry.
Excluded in open-label study patients:
3TC within 30 days prior to study entry.