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
NCT ID: NCT00002155
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
600 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Indinavir sulfate
Lamivudine
Zidovudine
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Locations
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Merck & Co Inc
Whitehouse Station, New Jersey, United States
Countries
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References
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Gulick RM, Mellors JW, Havlir D, Eron JJ, Gonzalez C, McMahon D, Richman DD, Valentine FT, Jonas L, Meibohm A, Emini EA, Chodakewitz JA. Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy. N Engl J Med. 1997 Sep 11;337(11):734-9. doi: 10.1056/NEJM199709113371102.
Hirsch M, Steigbigel R, Staszewski S, Mellors J, Scerpella E, Hirschel B, Lange J, Squires K, Rawlins S, Meibohm A, Leavitt R. A randomized, controlled trial of indinavir, zidovudine, and lamivudine in adults with advanced human immunodeficiency virus type 1 infection and prior antiretroviral therapy. J Infect Dis. 1999 Sep;180(3):659-65. doi: 10.1086/314948.
Other Identifiers
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039
Identifier Type: -
Identifier Source: secondary_id
246E
Identifier Type: -
Identifier Source: org_study_id