Expired Study
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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.


NCT ID:

NCT00002155


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Whitehouse Station, New Jersey 08889
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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