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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002155
• Other study ID #: 246E
• Secondary ID: 039
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Lamivudine

• Zidovudine

Locations

Country	Name	City	State
United States	Merck & Co Inc	Whitehouse Station	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation