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Completed

NCT Number: NCT00246610

Safety Of VIRACEPT® 625mg Administered To HIV-Infected Women During Pregnancy

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

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nelfinavir mesylate, 625 mg

Drug

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 names: VIRACEPT plus Combivir

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Adherence assessed using the NIAID ACTG Adherence Modules and by returned medication counts

    Time frame: 32 Weeks

  5. 12-hour pharmacokinetic evaluation of nelfinavir

    Time frame: 32 Weeks

  6. Maternal plasma HIV RNA

    Time frame: 32 Weeks

  7. Immunologic response as measured by CD4 and CD8 cell count

    Time frame: 32 Weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 31, 2005
Registry last updated
Apr 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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