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NCT00541463 Clinical Trial

A Study of Indinavir Plus Ritonavir Plus Two NRTIs vs. Nelfinavir Plus Two NRTIs in HIV Positive Patients (0639-112)(COMPLETED)

HIV Infections Clinical Trial

Official title:
A Multicenter, Open-Label, Randomized, Study to Compare the Efficacy and Safety of Indinavir 800 mg b.i.d. Plus Ritonavir 100 mg b.i.d. Plus Two NRTIs vs. Nelfinavir 1250 mg b.i.d. Plus Two NRTIs in HIV-1 Seropositive Patients Who Have Failed or Are Intolerant to an NNRTI Containing Regimen

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00541463
Other study ID # 0639-112
Secondary ID 2007_642
Status Completed
Phase Phase 2
First received October 9, 2007
Last updated February 16, 2017
Start date January 2001
Est. completion date May 2003

Study information
Verified date February 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A study comparing Indinavir plus Ritonavir plus 2 NRTIs vs. Nelfinavir 1250 plus two nucleoside reverse transcriptase inhibitors (NRTIs) in the treatment of HIV positive patients who have not responded to or are intolerant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) containing treatment.

Recruitment information / eligibility
Status Completed
Enrollment 330
Est. completion date May 2003
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- At least 18 years of age

- HIV positive

- No active heart disease

Exclusion Criteria:

- Pregnant or breast feeding

- Unwilling to use birth control or abstinence to prevent pregnancy

- Received an investigational drug or vaccine within the past 30 days or is planning to receive other investigational study drug/vaccine or interferon while in the study

- Plan to receive NNRTIs while in the study

- Received therapy which lowers body's ability to fight infection within the past 30 days or while in the study

- Alcohol or substance abuse

- Hepatitis

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks

• Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma viral RNA levels will be measured at predetermined time points to determine mean change
Secondary CD4 cell counts will be measured at predetermined time points to determine change from baseline
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