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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status

Completed

Conditions

HIV Infections

Treatments

Drug: Lamivudine
Drug: Indinavir sulfate
Drug: Zidovudine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002155
246E
039

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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