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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00541463

Enrollment

330

Registered

2007-10-10

Start date

2001-01-31

Completion date

2003-05-31

Last updated

2017-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Treatment Experienced

Brief 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.

Interventions

DRUGMK0639, indinavir sulfate / Duration of Treatment: 48 Weeks

DRUGComparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Plasma viral RNA levels will be measured at predetermined time points to determine mean change	—

Secondary

Measure	Time frame
CD4 cell counts will be measured at predetermined time points to determine change from baseline	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026