Pharmacokinetic Interactions Between DMPA and LPV/r Among HIV-Infected Women

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01296152
First received: February 14, 2011
Last updated: November 18, 2015
Last verified: November 2015
Results First Received: September 28, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1 Infection
Intervention: Drug: depo-medroxyprogesterone acetate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty-five HIV-1 infected women, ages 15 to 47 years, were recruited at 13 U.S. Clinical Research Sites and U.S. National Institute of Allergy and Infectious Diseases and National Institute of Child Health and Human Development-funded International Maternal Pediatric Adolescent AIDS Clinical Trial sites between June 1, 2011 and July 26, 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants: pre-menopausal HIV-1 infected females, >=13 years, plasma HIV-1 RNA <=400 copies/mL and cluster of differentiation 4 (CD4+) count >= 200 cells/mm^3 within 30 days prior to entry. Last menstrual period <=35 days prior to entry. If >35 days, follicle stimulating hormone (FSH) must have been <=40 Milli-International units/mL.

Reporting Groups
  Description
Depo-medroxyprogesterone Acetate (DMPA)

At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.

depo-medroxyprogesterone acetate: At study entry/ Day 0, participants will receive Depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.

Depo-medroxyprogesterone Acetate


Participant Flow:   Overall Study
    Depo-medroxyprogesterone Acetate (DMPA)  
STARTED     25  
COMPLETED     24  
NOT COMPLETED     1  
Unwilling to adhere to study requirement                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants enrolled.

Reporting Groups
  Description
Depo-medroxyprogesterone Acetate (DMPA)

At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.

depo-medroxyprogesterone acetate: At study entry/ Day 0, participants will receive Depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.

Depo-medroxyprogesterone Acetate


Baseline Measures
    Depo-medroxyprogesterone Acetate (DMPA)  
Number of Participants  
[units: participants]
  25  
Age  
[units: participants]
 
<=18 years     3  
Between 18 and 65 years     22  
>=65 years     0  
Age  
[units: years]
Median (Full Range)
  31   (15 to 47)  
Gender  
[units: participants]
 
Female     25  
Male     0  
Race/Ethnicity, Customized  
[units: participants]
 
White Non-Hispanic     3  
Black Non-Hispanic     15  
Hispanic (Regardless of Race)     6  
American Indian, Alaskan Native     1  
Region of Enrollment  
[units: participants]
 
United States     25  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Medroxyprogesterone Acetate (MPA) Pharmacokinetic Parameter (PK) Area Under the Concentration-time Curve (AUC0-12weeks)   [ Time Frame: Day 0, Weeks 2, 4, 6, 8, 10 and 12 ]

2.  Primary:   AUC0-12hour for LPV at Baseline (Day 0) Before DMPA Administration and at Week 4 (Four Weeks After DMPA Administration)   [ Time Frame: Day 0 and Week 4 ]

3.  Secondary:   Percentage of Participants With Progesterone Levels Less Than the Lower Limit of Quantification (LLQ).   [ Time Frame: 0, 2, 4, 6, 8, 10, and 12 weeks ]

4.  Secondary:   MPA PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on MPA Levels.   [ Time Frame: 0, 2, 4, 6, 8, 10, and 12 weeks ]

5.  Secondary:   MPA PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on MPA Levels.   [ Time Frame: 0, 2, 4, 6, 8, 10, and 12 weeks ]

6.  Secondary:   MPA PK Parameter Time to Cmax (Tmax) Determined Based on MPA Levels.   [ Time Frame: 0, 2, 4, 6, 8, 10, and 12 weeks ]

7.  Secondary:   MPA PK Parameter Clearance (CL/F) Determined Based on MPA Levels.   [ Time Frame: 0, 2, 4, 6, 8, 10, and 12 weeks ]

8.  Secondary:   MPA PK Parameter Half-Life (T1/2) Determined Based on MPA Levels.   [ Time Frame: 0, 2, 4, 6, 8, 10, and 12 weeks ]

9.  Secondary:   LPV PK Parameter Cmin.   [ Time Frame: Day 0 and Week 4 ]

10.  Secondary:   LPV PK Parameter Cmax.   [ Time Frame: Day 0 and Week 4 ]

11.  Secondary:   LPV PK Parameter Tmax.   [ Time Frame: Day 0 and Week 4 ]

12.  Secondary:   LPV PK Parameter CL/F.   [ Time Frame: Day 0 and Week 4 ]

13.  Secondary:   LPV PK Parameter T1/2.   [ Time Frame: Day 0 and Week 4 ]

14.  Secondary:   Ritonavir (RTV) PK Parameter AUC0-12h.   [ Time Frame: Day 0 and Week 4 ]

15.  Secondary:   RTV PK Parameter Cmin.   [ Time Frame: Day 0 and Week 4 ]

16.  Secondary:   RTV PK Parameter Cmax.   [ Time Frame: Day 0 and Week 4 ]

17.  Secondary:   RTV PK Parameter Tmax.   [ Time Frame: Day 0 and Week 4 ]

18.  Secondary:   RTV PK Parameter CL/F.   [ Time Frame: Day 0 and Week 4 ]

19.  Secondary:   RTV PK Parameter T1/2.   [ Time Frame: Day 0 and Week 4 ]

20.  Secondary:   Percentage of Participants With Menstrual Irregularities of Grade 1 and Higher Deemed Possibly, Probably or Definitely Related to Study Treatment.   [ Time Frame: From day 0 to week 12 ]

21.  Secondary:   Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL.   [ Time Frame: Day 0, Weeks 2, 4, 8, and 12 ]

22.  Secondary:   Cell Mediated Immunity (CMI) to HIV and the Common Opportunistic Agent Varicella-zoster Virus (VZV) Using the Enzyme-linked Immunospot (ELISPOT) Assay.   [ Time Frame: Day 0, Weeks 4 and 12 ]

23.  Secondary:   CMI to HIV and the Common Opportunistic Agent VZV Using the Lymphocyte Proliferation Assay (LPA).   [ Time Frame: Day 0, Weeks 4 and 12 ]

24.  Secondary:   Regulatory T Cells (Tregs) at Baseline, Week 4 and Week 12 Using Flow Cytometry in Freshly Thawed PBMCs.   [ Time Frame: Day 0, Weeks 4 and 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
phone: (301) 628-3313
e-mail: ACTGCT.Gov@s-3.com


Publications of Results:
Other Publications:
The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009)


Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01296152     History of Changes
Other Study ID Numbers: ACTG A5283
1U01AI068636 ( US NIH Grant/Contract Award Number )
Study First Received: February 14, 2011
Results First Received: September 28, 2015
Last Updated: November 18, 2015
Health Authority: United States: Federal Government