Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen
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ClinicalTrials.gov Identifier: NCT00051844 |
Recruitment Status :
Completed
First Posted : January 20, 2003
Last Update Posted : May 10, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Immunodeficiency Virus | Drug: Capravirine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 179 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Double Blind- Randomized, Placebo-controlled Study of Two Doses of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Infected Patients Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen |
Study Start Date : | August 2002 |
Actual Study Completion Date : | November 2004 |
- The primary objective was to determine whether the addition of capravirine to a regimen of VIRACEPT and 2 new nucleoside reverse transcriptase inhibitors would provide a higher virologic response rate over 48 weeks
- when compared to a 3-drug regimen without capravirine in patients who had experienced virologic failure while on a nonnucleoside reverse transcriptase inhibitor regimen.
- The safety and tolerability of 2 doses of capravirine.
- The difference between 2 doses of capravirine in terms of tolerability, efficacy, and pharmacokinetics
- The relationship of HIV resistance (genotype and phenotype) to virologic response.
- The immunologic response as determined by CD4 and CD8 absolute lymphocyte counts
- The population pharmacokinetics of capravirine and VIRACEPT
- The pharmacokinetics of potential drug-drug interactions.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female at least 18 years old
- HIV RNA level >1000 copies/mL at screening
- CD4 >50 cells/uL at screening
- Patient is currently taking a regimen that includes an NNRTI plus 2 NRTIs for at least 28 days and is currently failing this regimen
- Patient has adequate hematology tests (absolute neutrophil count >1000/uL, Platelets>75,000uL, hemoglobin 9g/L)
- Patient has adequate renal function (serum creatinine of <1.5 upper limit of normal)
- Patient has adequate liver function (AST, ALT, and bilirubin < 2.5 upper limit of normal)
Exclusion Criteria:
- Previous use of protease inhibitors (except if patient has short duration of PI and was switched for tolerability reasons when viral load was <50 copies) This exception does not include Viracept
- Women who are pregnant or lactating

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051844

Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT00051844 |
Other Study ID Numbers: |
A4311002 |
First Posted: | January 20, 2003 Key Record Dates |
Last Update Posted: | May 10, 2011 |
Last Verified: | May 2011 |
HIV NNRTI Failure HIV Infections |
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Slow Virus Diseases Capravirine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents |