Clinical trial NCT00002393: A Study of Indinavir Taken With or Without DMP 266
Official title: A Phase III, Double-Blind, Placebo-Controlled, Multicenter Study to Determine the Effectiveness and Tolerability of the Combination of DMP 266 and Indinavir Versus Indinavir in HIV-Infected Patients Receiving Nucleoside Analogue (NRTI) Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Placebos
Drug Therapy, Combination
HIV Protease Inhibitors
Indinavir
Reverse Transcriptase Inhibitors
efavirenz
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 300
Sex: ALL
Minimum age (years): 13
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to add DMP 266 to an anti-HIV treatment program of indinavir and nucleoside reverse transcriptase inhibitors (NRTIs).

Detailed description: In this double-blind, placebo-controlled study, 300 patients are randomized to 1 or 2 reverse transcriptase inhibitors of their choice plus blinded therapy on Arm A or B as follows:

Arm A: DMP 266 placebo plus indinavir. Arm B: DMP 266 plus indinavir. After 16 weeks, patients may switch the NRTI portion of their regimen if they meet a treatment failure criterion. After the completion of the 24-week period, patients have the option to continue on open-label DMP 266 and indinavir.

Eligibility criteria: Inclusion Criteria

Patients must have:

* CD4+ cell count of at least 50 cells/mm3.
* HIV RNA level of at least 10,000 copies/ml by reverse transcriptase polymerase chain reaction (RT-PCR, Amplicor test kit) at screening.
* Signed, informed consent from parent or legal guardian for patients less than 18 years of age.

Exclusion Criteria

Prior Medication:

Excluded:

* DMP 266.
* Other nonnucleoside reverse transcriptase inhibitors.

Required:

One or two NRTIs (except ZDV and d4T in combination) for a minimum of 8 weeks, within 12 weeks prior to screening.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Kaiser Foundation Hospital
state: California
city: Augusta
country: United States
facility: Med College of Georgia
state: Georgia
city: Chicago
country: United States
facility: Chicago Ctr for Clinical Research
state: Illinois
city: Lexington
country: United States
facility: Univ of Kentucky Med Ctr / Chandler Med Ctr
state: Kentucky
city: New Orleans
country: United States
facility: Tulane Univ / Tulane / LSU Clinical Trials Unit
state: Louisiana
city: New York
country: United States
facility: Mount Sinai Med Ctr
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Med Ctr
state: New York
city: Nashville
country: United States
facility: Vanderbilt Univ
state: Tennessee
city: Hampton
country: United States
facility: Hampton Roads Med Specialists
state: Virginia
city: Calgary
country: Canada
facility: Southern Alberta HIV Clinic / Foot Hills Hosp
state: Alberta
city: Ottawa
country: Canada
facility: Ottawa Gen Hosp
state: Ontario
city: San Juan
country: Puerto Rico
facility: Univ of Puerto Rico School of Medicine
Study officials:
References:
citation: Haas DW, Fessel WJ, Delapenha RA, Kessler H, Seekins D, Kaplan M, Ruiz NM, Ploughman LM, Labriola DF, Manion DJ. Therapy with efavirenz plus indinavir in patients with extensive prior nucleoside reverse-transcriptase inhibitor experience: a randomized, double-blind, placebo-controlled trial. J Infect Dis. 2001 Feb 1;183(3):392-400. doi: 10.1086/318083. Epub 2000 Dec 29.