Phase III PEG-Intron in HIV-infected Patients (Study P00738)

Tracking Information
First Submitted Date ICMJE	May 2, 2002
First Posted Date ICMJE	May 6, 2002
Last Update Posted Date	March 10, 2017
Study Start Date ICMJE	March 2002
Actual Primary Completion Date	October 2003 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00035360 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Phase III PEG-Intron in HIV-infected Patients (Study P00738)
Official Title ICMJE	Phase 3 Study of PEG-Intron in Heavily Treatment-experienced, HIV-infected Patients
Brief Summary	This is a randomized, double-blind, multicenter trial testing 2 doses of PEG-Intron, 1.0mcg/kg/week and 3.0mcg/kg/week in heavily treatment-experienced HIV-infected patients compared to placebo. The study will evaluate the efficacy and safety of PEG-Intron when added to stable optimized background antiretroviral therapy in this patient population.
Detailed Description	This study will randomize 675 patients (225 in each of the 3 arms) to either: PEG-Intron 1mcg; 3mcg or Placebo, at 90 centers worldwide. Each center will enroll approximately 10 patients. Study drug will be added to optimized background anti-retroviral therapy of patients whose HIV RNA is incompletely suppressed by their therapy (HIV RNA 400-50,000 copies/ML) after 2-6 months. A single dose reduction of 50% will be allowed for toxicity. An Interim Analysis will be conducted when 50% of patients have completed 24 weeks of therapy. The study treatment phase will be 48 weeks with monthly visits for virologic virologic and safety monitoring. The primary endpoint is change in HIV RNA from baseline to week to assess efficacy. Durability of response will be assessed at 48 weeks.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	HIV Infections; AIDS
Intervention ICMJE	Drug: PEG-Intron
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 25, 2014)	49
Original Enrollment ICMJE; (submitted: June 23, 2005)	675
Actual Study Completion Date	October 2003
Actual Primary Completion Date	October 2003 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: HIV positive; History of virologic failure on at least 2 antiretroviral regimens including exposure to at least one NRTI, one NNRTI and one PI; HIV RNA >400-<50,000 copies/mL; Laboratory parameters: platelet count (75,000u/L, hemoglobin >9gm/dl, absolute neutrophil count >1,000/uL, SGOT/SGPT<5xULN. Exclusion Criteria: Current ribavirin therapy; Subjects with a recent diagnosis or history of moderate or severe depression requiring ongoing psychiatric intervention; Females of childbearing potential who are breastfeeding, who are pregnant, or not using adequate birth control measures; Concomitant use of immunosuppressants or cytotoxic agents; History of seizure disorder requiring use of anticonvulsants
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	Argentina, Brazil, Mexico, Peru, Puerto Rico, Singapore, South Africa, Spain, United States
Administrative Information
NCT Number ICMJE	NCT00035360
Other Study ID Numbers ICMJE	P00738
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Merck Sharp & Dohme Corp.
Study Sponsor ICMJE	Merck Sharp & Dohme Corp.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Merck Sharp & Dohme Corp.
Verification Date	March 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP