Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to administer a combined oral contraceptive containing ethinyl estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to assess if the concentrations of the oral contraceptives change. The safety of this treatment regimen will also be studied.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Active Comparator |
| |
| C | Active Comparator |
| |
| D | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ortho Tri-Cyclen LO | Drug | Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate | throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the pharmacokinetics of efavirenz coadministered with the oral contraceptive Ortho Cyclen | throughout the study | |
| Assess the effect of efavirenz coadministered with Ortho Cyclen on serum progesterone levels | throughout the study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit San Diego | San Diego | California | 92123 | United States | ||
| Northwest Kinetics |
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ortho Cyclen |
| Drug |
Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days. |
|
| Ortho Cyclen + Efavirenz | Drug | Tablet, oral, OC + EFV 600 mg, once daily, 14 days. |
|
|
| Ortho Cyclen | Drug | Tablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days. |
|
| Assess the safety of efavirenz coadministered with Ortho Cyclen | throughout the study |
| Tacoma |
| Washington |
| 98418 |
| United States |
| 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 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |