Overview

A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Antiviral Agents
Indinavir
Lamivudine
Zidovudine
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.