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 - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002155 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	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 ^ICMJE	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
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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Indinavir sulfate Drug: Lamivudine Drug: Zidovudine
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	600
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002155
Responsible Party
Study ID Numbers ^ICMJE	246E, 039
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	June 1996
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP