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

Back to Search
Print
Bookmark Trial

NCT00052117

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

HIV InfectionsFour-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens NCT00052117
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HIV InfectionsStudy Evaluating Vaccine in Adults With HIV NCT00195234
  1. Sacramento, California
  2. Denver, Colorado
  3. Chicago, Illinois
  4. New York, New York
  5. Cleveland, Ohio
  6. Philadelphia, Pennsylvania
  7. Nashville, Tennessee
  8. Austin, Texas
  9. Dallas, Texas
  10. Dallas, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HIV InfectionsStudy Evaluating Vaccine in Adults With HIV NCT00195312
  1. Birmingham, Alabama
  2. Denver, Colorado
  3. Orlando, Florida
  4. Boston, Massachusetts
  5. Austin, Texas
  6. Dallas, Texas
  7. Berlin,
  8. Frankfurt,
  9. Hamburg,
  10. Hannover,
  11. Köln,
  12. München,
  13. Stockholm,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HIV InfectionsA Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease NCT00002033
  1. Sao Paulo,
  2. Sao Paulo,
  3. Sao Paulo,
  4. Sao Paulo,
ALL GENDERS
13 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: capravirine
  • Drug: Kaletra
  • Drug: 2 NRTIs
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)		300
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Argentina,   Brazil,   Canada,   France,   Mexico,   Netherlands,   South Africa,   Spain,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT00052117
Other Study ID Numbers  ICMJE A4311006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP