Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients - 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 NCT00002375 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients
Official Title ^ICMJE	A Multicenter, 24-Week Study of the Safety, Pharmacokinetics, and Activity of the Coadministration of Indinavir and Nelfinavir in HIV-1 Seropositive Patients
Brief Summary	The purpose of this study is to see if it is safe and effective to treat HIV-infected patients with indinavir (IDV) plus nelfinavir (NFV), 2 anti-HIV medications. It is thought that IDV plus NFV will be a safe drug combination for treating HIV.
Detailed Description	It is hypothesized that the administration of indinavir with nelfinavir will be generally safe and well tolerated. This is a parallel, time-lagged, 2-stage, multiple-dose, 24-week study in HIV-1 seropositive patients. In the 3-week, randomized, double-blind phase of Stage A, patients receive either indinavir plus nelfinavir (Group A1: 9 patients) or indinavir placebo plus nelfinavir placebo (Group A2: 3 patients) for the first week. In Week 2, patients in Group A1 have the nelfinavir dose increased. This dose escalation for nelfinavir is contingent upon the patient having completed 1 week of the study drugs without experiencing Grade 3 or worse toxicity and/or serious drug-related adverse events. Patients in Group A2 continue to receive placebo until Week 3, at which time they receive indinavir plus nelfinavir (initial dose), while patients in Group A1 continue with indinavir plus nelfinavir (escalated dose). At Week 4 all patients in Stage A (including those originally assigned to receive placebo) receive open-label indinavir plus nelfinavir (escalated dose) for the remainder of the 24 weeks. After at least 6 patients in Stage A have completed at least 2 weeks of therapy with nelfinavir plus indinavir with acceptable tolerability, Stage B begins. In the 2-week, randomized, double-blind phase of Stage B, patients receive either indinavir plus nelfinavir (Group B1: 9 patients) or indinavir placebo plus nelfinavir placebo (Group B2, 3 patients). After 2 weeks, all patients in Stage B (including those originally assigned to receive placebo) receive open-label indinavir plus nelfinavir for the remainder of the 24 weeks.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Parallel Assignment, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Indinavir sulfate Drug: Nelfinavir mesylate
Study Arms / Comparison Groups
Publications *
* 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	24
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have a CD4 count of at least 100 cells/mm3. Have a plasma viral load (level of HIV in the blood) of at least 30,000 copies/ml. Are at least 18 years old. Exclusion Criteria You will not be eligible for this study if you: Have ever been treated with any protease inhibitors (PIs).
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	NCT00002375
Responsible Party
Study ID Numbers ^ICMJE	246H, MK-0639, 061-00
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	February 2000
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP