Safety Of VIRACEPT® 625mg Administered To HIV-Infected Women During Pregnancy
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ClinicalTrials.gov Identifier: NCT00246610 |
Recruitment Status
:
Completed
First Posted
: October 31, 2005
Last Update Posted
: April 28, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Drug: Nelfinavir mesylate, 625 mg | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | November 2007 |
Actual Study Completion Date : | November 2007 |

Arm | Intervention/treatment |
---|---|
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
|
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Adherence assessed using the NIAID ACTG Adherence Modules and by returned medication counts [ Time Frame: 32 Weeks ]
- 12-hour pharmacokinetic evaluation of nelfinavir [ Time Frame: 32 Weeks ]
- Maternal plasma HIV RNA [ Time Frame: 32 Weeks ]
- Immunologic response as measured by CD4 and CD8 cell count [ Time Frame: 32 Weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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): NCT00246610
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc. |
ClinicalTrials.gov Identifier: | NCT00246610 History of Changes |
Other Study ID Numbers: |
A4301017 |
First Posted: | October 31, 2005 Key Record Dates |
Last Update Posted: | April 28, 2011 |
Last Verified: | April 2011 |
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:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Nelfinavir Lamivudine, zidovudine drug combination |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |