NCT00052117

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started Jan 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

October 10, 2007

Status Verified

October 1, 2007

First QC Date

January 22, 2003

Last Update Submit

October 5, 2007

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • To determine the optimal safe and effective dose of capravirine in combination with Kaletra plus at least 2 NRTIs

Secondary Outcomes (4)

  • the relationship of HIV baseline resistance (genotype and phenotype) to virologic outcome

  • 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

  • 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)

Interventions

capravirineDRUG
KaletraDRUG
2 NRTIsDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV Infections

Interventions

capravirinelopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 22, 2003

First Posted

January 23, 2003

Study Start

January 1, 2003

Study Completion

May 1, 2005

Last Updated

October 10, 2007

Record last verified: 2007-10