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 - Full Text View

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

MedlinePlus related topics:

AIDS

Drug Information available for:

Zidovudine Lamivudine Indinavir Indinavir Sulfate

U.S. FDA Resources

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

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
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002155
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:

Virus Diseases

Sexually Transmitted Diseases, Viral

Indinavir

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Lamivudine

Zidovudine

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

HIV Protease Inhibitors

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Protease Inhibitors

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008

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