HIV Infection
Conditions
Keywords
Non-randomized open-label single-arm study of Nelfinavir plus Combivir in pregnant females infected with HIV-1 virus.
Brief summary
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
Interventions
DRUGNelfinavir 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.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 32 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 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 | 32 Weeks |
| Adherence assessed using the NIAID ACTG Adherence Modules and by returned medication counts | 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 | 32 Weeks |
| Maternal plasma HIV RNA | 32 Weeks |
| Immunologic response as measured by CD4 and CD8 cell count | 32 Weeks |
| 12-hour pharmacokinetic evaluation of nelfinavir | 32 Weeks |
Countries
Canada, United States
Outcome results
None listed