Safety Of VIRACEPT® 625mg Administered To HIV-Infected Women During Pregnancy
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00246610
First received: October 28, 2005
Last updated: April 26, 2011
Last verified: April 2011
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Purpose
This study is an evaluation of the safety of 625 mg formulation when administered to HIV-infected pregnant women from their second trimester through six weeks postpartum. The study will also evaluate the pharmacokinetics of VIRACEPT
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: Nelfinavir mesylate, 625 mg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase IV, Non-Randomized, Open-Label Trial Evaluating The Safety Of 625 mg Formulation Of VIRACEPT When Administered To HIV-Infected Women During Pregnancy |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Presence or absence of at least one adverse event related to or possibly related to nelfinavir of Grade 2 or greater severity as defined by the DAIDS Table for Grading of Severity of Adult Adverse Experiences in the gastrointestinal or hepatic category [ Time Frame: 32 Weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Development of primary or active site protease and nucleoside reverse transcriptase inhibitor-associated resistance mutations assessed using standard HIV genotype test on maternal plasma samples [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]
- Presence or absence of at least one adverse event of Grade 3 or 4 severity in the hematologic, cardiovascular or metabolic categories defined by DAIDS Table or in the dermatologic category as defined by the Supplemental Toxicity Table [ Time Frame: 32 Weeks ] [ Designated as safety issue: Yes ]
- Adverse pregnancy events which cannot be directly attributed to another cause other than study treatment after consultation with Pfizer Clinician and Site Investigator [ Time Frame: 32 Weeks ] [ Designated as safety issue: Yes ]
- Adherence assessed using the NIAID ACTG Adherence Modules and by returned medication counts [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]
- 12-hour pharmacokinetic evaluation of nelfinavir [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]
- Maternal plasma HIV RNA [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]
- Immunologic response as measured by CD4 and CD8 cell count [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]
| Enrollment: | 16 |
| Study Start Date: | March 2006 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Open-label
Non-randomized, open-label, single-arm
|
Drug: Nelfinavir mesylate, 625 mg
Nelfinavir 625 mg [dosed orally as 1250 mg BID (two 625 mg tablets given orally BID)] plus Combivir (lamivudine 150 mg plus zidovudine 300 mg BID dosed orally) administered with food. Subjects will start treatment at their baseline visit. Subjects will be treated for up to 26 weeks during pregnancy plus 6 weeks postpartum.
Other Name: VIRACEPT plus Combivir
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV infection
- Second trimester of pregnancy
Exclusion Criteria:
- Major current or prior history of obstetrical complications
- Serious current medical diseases
- Evidence of HIV virus resistance to antiretroviral agents
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246610
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246610
Locations
| United States, Florida | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32209 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33136 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Metairie, Louisiana, United States, 70006 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Detroit, Michigan, United States, 48201 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19410 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M5G 2N2 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc. |
| ClinicalTrials.gov Identifier: | NCT00246610 History of Changes |
| Other Study ID Numbers: | A4301017 |
| Study First Received: | October 28, 2005 |
| Last Updated: | April 26, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Non-randomized open-label single-arm study of Nelfinavir plus Combivir in pregnant females infected with HIV-1 virus. |
Additional relevant MeSH terms:
|
Nelfinavir Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors |
HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015