Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000897
Status:
COMPLETED
Last Update Posted:
2011-03-02
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Effects of Different Methods of Birth Control on the Drug Actions of Zidovudine an Anti-HIV Drug in HIV-Positive Women and to Compare Zidovudine Metabolism in Men and Women
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Effect of Oral and Injectable Contraceptives NorethindroneEthinyl Estradiol Medroxyprogesterone Acetate and Gender on Plasma and Intracellular Zidovudine Pharmacokinetics
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to look at the effects of different methods of birth control oral and injectable on how the body absorbs makes available and removes zidovudine ZDV This study will also evaluate the differences in men and women in how the body absorbs makes available and removes ZDV
Past research has shown that the effectiveness of ZDV as an anti-HIV drug might be decreased in individuals who use certain methods of birth control ZDV may also have different effects in men compared to women
Past research has shown that the effectiveness of ZDV as an anti-HIV drug might be decreased in individuals who use certain methods of birth control ZDV may also have different effects in men compared to women
Detailed Description:
Oral contraceptives have been shown to substantially enhance the glucuronidation of several compounds One study reported enhanced glucuronidation of oxazepam a compound that is conjugated via the same UDP-glucuronyl transferase isozyme responsible for ADV glucuronidation suggesting that ZDV metabolism may be altered by concomitant oral contraceptive use This potential enhancement of ZDV metabolism by oral contraceptives is expected to result in decreased plasma levels of the parent compound which may lead to diminished clinical efficacy in women using these drugs It remains unclear whether the progesterone andor estrogen component of oral contraceptives results in the observed glucuronidation changes
This open-label pharmacokinetic trial is conducted in 2 steps AS PER AMENDMENT 61201 The Depo-Provera IM group in Step 2 is filled Female patients who choose to participate in Step 2 may enroll only in the Ortho-Novum 135 PO group AS PER AMENDMENT 111300 Female patients may choose to participate in Step 1 alone or both Steps 1 and 2 Male patients may participate in Step 1 only as the control arm of the study In Step 1 patients are stratified by sex in Step 2 female patients are stratified by their choice of contraception ie oral norethindroneethinyl estradiol Ortho-Novum 135 or injectable medroxyprogesterone acetate Depo-Provera
Step 1 males and females At entry all patients are randomized to receive ZDV either orally or orally and intravenously IV on Days 7 and 8 Female patients begin the study Day 0 between days 10-18 after the first day of their last menstrual period LMP Cycle 1 At time of enrollment female patients AS PER AMENDMENT 111300 who plan to participate in Step 2 choose the form of birth control instituted in Step 2 Depo-Provera or Ortho-Novum 135 Male patients may enter Step 1 at any time Patients continue taking their other pre-study antiretroviral drugs during Step 1 AS PER AMENDMENT 6399 Patients taking nelfinavir may participate only in the Depo-Provera arm Days 0-6 All patients receive oral ZDV Day 7 Patients are randomized to receive
Arm 1 females oral ZDV for a total of 3 doses Arm 2 females ZDV IV then ZDV orally for a total of 2 oral doses Arm 3 males control arm Half of the male patients receive ZDV as in Arm 1 and the other male patients receive ZDV as in Arm 2
Day 8 Patients on all 3 arms receive the alternate form of ZDV to that received on Day 7 Day 9 Female patients resume their pre-study method of administration of ZDV Male patients conclude their participation in the study on Day 8
Step 2 females AS PER AMENDMENT 111300 opting to participate in Step 2 At the onset of their second menstrual period Cycle 2 since starting study female patients start their choice of Ortho-Novum 135 or intramuscularly administered Depo-Provera AS PER AMENDMENT 61201 Enrollment for Depo-Provera is closed Contraceptive therapy continues throughout Step 2 Step 2 Days 0-6 Between days 7-11 AS PER AMENDMENT 6399 Between days 7-18 of the third menstrual cycle Cycle 3 since starting study female patients continue their pre-study antiretroviral therapy as done in Step 1 and begin another course of ZDV standard therapy 3 times daily Days 7-8 Patients receive the original method of administration of ZDV as randomized at study entry Female patients return for a final safety visit within 1 week of completing study Day 8 of Step 2
This open-label pharmacokinetic trial is conducted in 2 steps AS PER AMENDMENT 61201 The Depo-Provera IM group in Step 2 is filled Female patients who choose to participate in Step 2 may enroll only in the Ortho-Novum 135 PO group AS PER AMENDMENT 111300 Female patients may choose to participate in Step 1 alone or both Steps 1 and 2 Male patients may participate in Step 1 only as the control arm of the study In Step 1 patients are stratified by sex in Step 2 female patients are stratified by their choice of contraception ie oral norethindroneethinyl estradiol Ortho-Novum 135 or injectable medroxyprogesterone acetate Depo-Provera
Step 1 males and females At entry all patients are randomized to receive ZDV either orally or orally and intravenously IV on Days 7 and 8 Female patients begin the study Day 0 between days 10-18 after the first day of their last menstrual period LMP Cycle 1 At time of enrollment female patients AS PER AMENDMENT 111300 who plan to participate in Step 2 choose the form of birth control instituted in Step 2 Depo-Provera or Ortho-Novum 135 Male patients may enter Step 1 at any time Patients continue taking their other pre-study antiretroviral drugs during Step 1 AS PER AMENDMENT 6399 Patients taking nelfinavir may participate only in the Depo-Provera arm Days 0-6 All patients receive oral ZDV Day 7 Patients are randomized to receive
Arm 1 females oral ZDV for a total of 3 doses Arm 2 females ZDV IV then ZDV orally for a total of 2 oral doses Arm 3 males control arm Half of the male patients receive ZDV as in Arm 1 and the other male patients receive ZDV as in Arm 2
Day 8 Patients on all 3 arms receive the alternate form of ZDV to that received on Day 7 Day 9 Female patients resume their pre-study method of administration of ZDV Male patients conclude their participation in the study on Day 8
Step 2 females AS PER AMENDMENT 111300 opting to participate in Step 2 At the onset of their second menstrual period Cycle 2 since starting study female patients start their choice of Ortho-Novum 135 or intramuscularly administered Depo-Provera AS PER AMENDMENT 61201 Enrollment for Depo-Provera is closed Contraceptive therapy continues throughout Step 2 Step 2 Days 0-6 Between days 7-11 AS PER AMENDMENT 6399 Between days 7-18 of the third menstrual cycle Cycle 3 since starting study female patients continue their pre-study antiretroviral therapy as done in Step 1 and begin another course of ZDV standard therapy 3 times daily Days 7-8 Patients receive the original method of administration of ZDV as randomized at study entry Female patients return for a final safety visit within 1 week of completing study Day 8 of Step 2
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AACTG 317 | None | None | None |