Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens

A Phase 2, Randomized, Double-Blind, Dose-Ranging Study Of Capravirine (AG1549) In Combination With Kaletra (Trademark) and At Least 2 Nucleoside Reverse Transcriptase Inhibitors in Hiv-Infected Subjects Who Have Failed Antiretroviral Regimens Containing Protease Inhibitors, Nonnucleoside Reverse Transcriptase Inhibitors, and Nucleoside Reverse Transcriptase Inhibitors

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00052117

Enrollment

300

Registered

2003-01-23

Start date

2003-01-31

Completion date

2005-05-31

Last updated

2007-10-10

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

Conditions

HIV Infections

Brief summary

This is a 48 week study for HIV-infected patients who have failed several regimens including PI's, NNRTs and NRTIs. Patients will be randomly selected to be in 1 of 4 groups. Three of the 4 groups will contain capravirine in different doses combined with Kaletra and nucleosides and one of the groups will be a combination of Kaletra and nucleosides without the capravirine.

Interventions

DRUGcapravirine

DRUGKaletra

DRUG2 NRTIs

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* HIV-infected male or female at least 18 years of age * HIV RNA level \>1000 copies/mL at screening * Subject has failed regimens that included at least 1 protease inhibitor but not more than 3 protease inhibitors, at least 1 nonnucleoside reverse transcriptase inhibitor, and least 2 nucleoside reverse transcriptase inhibitors * Adequate renal function * Adequate hematological function * Adequate liver function

Exclusion criteria

* Women who are pregnant or lactating * No previous experience with Kaletra

Design outcomes

Primary

Measure	Time frame
To determine the optimal safe and effective dose of capravirine in combination with Kaletra plus at least 2 NRTIs	—

Secondary

Measure	Time frame
the population pharmacokinetics of capravirine and lopinavir/ritonavir (Kaletra) using mixed-effects modeling	—
the pharmacokinetic drug-drug interactions between capravirine and Kaletra and selected concomitant medications	—
the relationship of HIV baseline resistance (genotype and phenotype) to virologic outcome	—
changes in subject-reported health status and HIV symptoms using the Medical Outcomes Study - HIV Health Survey (MOS-HIV) and the Symptoms Distress Module (National Institute of Allergy and Infectious Diseases Adult AIDS Clinical Trials Group)	—

Outcome results

None listed

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