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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00052117
• Collaborator: (none)
• Enrollment: 300
• Duration (Months): 28

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: capravirine; Drug: Kaletra; Drug: 2 NRTIs	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Jan 1, 2003
• Study Completion Date: May 1, 2005

Outcome Measures

Primary Outcome Measures

1. To determine the optimal safe and effective dose of capravirine in combination with Kaletra plus at least 2 NRTIs []

Secondary Outcome Measures

1. the relationship of HIV baseline resistance (genotype and phenotype) to virologic outcome []

2. the population pharmacokinetics of capravirine and lopinavir/ritonavir (Kaletra) using mixed-effects modeling []

3. the pharmacokinetic drug-drug interactions between capravirine and Kaletra and selected concomitant medications []

4. 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) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00052117
• Other Study ID Numbers: A4311006
• First Posted: Jan 23, 2003
• Last Update Posted: Oct 10, 2007
• Last Verified: Oct 1, 2007

• Additional relevant MeSH terms: HIV Infections; Capravirine

Study Results

No Results Posted as of Oct 10, 2007