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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indinavir sulfate
Lamivudine
Zidovudine
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antiviral Agents, Zidovudine, HIV Protease Inhibitors, Lamivudine, Indinavir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Merck & Co Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00002155
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antiviral Agents, Zidovudine, HIV Protease Inhibitors, Lamivudine, Indinavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Merck & Co Inc
City
Whitehouse Station
State/Province
New Jersey
ZIP/Postal Code
088890100
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9287228
Citation
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.
Results Reference
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PubMed Identifier
10438352
Citation
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.
Results Reference
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Learn more about this trial

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

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