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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Merck
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002155

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.

Condition	Intervention
HIV Infections	Drug: Indinavir sulfate Drug: Lamivudine Drug: Zidovudine

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Lamivudine Indinavir Indinavir Sulfate

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

600

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002155

Locations

United States, New Jersey
Merck & Co Inc
Whitehouse Station, New Jersey, United States, 088890100

Sponsors and Collaborators

Merck

More Information

Publications:

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.

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.

Study ID Numbers:	246E, 039
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002155 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Antiviral Agents
Zidovudine

HIV Protease Inhibitors
Lamivudine
Indinavir

Study placed in the following topic categories:

Antimetabolites
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Indinavir
Acquired Immunodeficiency Syndrome
Zidovudine
Lamivudine
Antiviral Agents

Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Indinavir
Molecular Mechanisms of Pharmacological Action
Zidovudine
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on July 02, 2009