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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label | Experimental | Non-randomized, open-label, single-arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Jacksonville | Florida | 32209 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D019888 | Nelfinavir |
| C109078 | lamivudine, zidovudine drug combination |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| 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 |
| 12-hour pharmacokinetic evaluation of nelfinavir | 32 Weeks |
| Maternal plasma HIV RNA | 32 Weeks |
| Immunologic response as measured by CD4 and CD8 cell count | 32 Weeks |
| Miami |
| Florida |
| 33136 |
| United States |
| Pfizer Investigational Site | Metairie | Louisiana | 70006 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48201 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19410 | United States |
| Pfizer Investigational Site | Toronto | Ontario | M5G 2N2 | Canada |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |