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

Last updated on May 11, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Women who are pregnant or lactating

- No previous experience with Kaletra

NCT00052117
Pfizer
Completed
Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens

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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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
HIV Infections
  • Drug: capravirine
  • Drug: Kaletra
  • Drug: 2 NRTIs
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
May 2005
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Argentina,   Brazil,   Canada,   France,   Mexico,   Netherlands,   South Africa,   Spain,   United Kingdom,   United States
 
NCT00052117
A4311006
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

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1-800-718-1021

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Contact

[email protected]



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