Trial Outcomes & Findings for Effect of Gender and HIV Infection on Zidovudine and Lamivudine Pharmacokinetics (NCT NCT01386970)
NCT ID: NCT01386970
Last Updated: 2020-03-16
Results Overview
To compare ZDV- triphosphate concentrations in HIV-negative versus HIV-infected subjects.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
43 participants
Primary outcome timeframe
Day 12 of dosing
Results posted on
2020-03-16
Participant Flow
Participant milestones
| Measure |
HIV-negative
This group was used to compare intracellular ZDV- and 3TC-triphosphate concentrations to the HIV-infected group and in men versus women.
zidovudine 300mg and lamivudine 150mg as Combivir: twice daily for 12 days in the HIV-negative group
|
HIV-infected
This group was started on ZDV-3TC based therapy. Intracellular ZDV- and 3TC-triphosphate concentrations were compared in men versus women and the HIV-negative group.
zidovudine 300mg and lamivudine 150mg as Combivir: indefinitely for their care in the HIV-positive group
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
23
|
|
Overall Study
COMPLETED
|
16
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
HIV-negative
This group was used to compare intracellular ZDV- and 3TC-triphosphate concentrations to the HIV-infected group and in men versus women.
zidovudine 300mg and lamivudine 150mg as Combivir: twice daily for 12 days in the HIV-negative group
|
HIV-infected
This group was started on ZDV-3TC based therapy. Intracellular ZDV- and 3TC-triphosphate concentrations were compared in men versus women and the HIV-negative group.
zidovudine 300mg and lamivudine 150mg as Combivir: indefinitely for their care in the HIV-positive group
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Adverse Event
|
4
|
1
|
Baseline Characteristics
Effect of Gender and HIV Infection on Zidovudine and Lamivudine Pharmacokinetics
Baseline characteristics by cohort
| Measure |
HIV-negative
n=20 Participants
This group was used to compare intracellular ZDV- and 3TC-triphosphate concentrations to the HIV-infected group and in men versus women.
zidovudine 300mg and lamivudine 150mg as Combivir: twice daily for 12 days in the HIV-negative group
|
HIV-infected
n=23 Participants
This group was started on ZDV-3TC based therapy. Intracellular ZDV- and 3TC-triphosphate concentrations were compared in men versus women and the HIV-negative group.
zidovudine 300mg and lamivudine 150mg as Combivir: indefinitely for their care in the HIV-positive group
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non- African-American
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 12 of dosingTo compare ZDV- triphosphate concentrations in HIV-negative versus HIV-infected subjects.
Outcome measures
| Measure |
HIV-negative
n=20 Participants
This group was used to compare intracellular ZDV-triphosphate concentrations to the HIV-infected group
zidovudine 300mg twice daily for 12 days in the HIV-negative group
|
HIV-infected
n=23 Participants
This group was used to compare intracellular ZDV-triphosphate concentrations to the HIV-infected group
zidovudine 300mg twice daily for 12 days in the HIV-negative group
|
|---|---|---|
|
ZDV-TP Drug Levels Compared Between HIV Negative and HIV Infected Subject
|
33.89 pmol/10^6 cells
Interval 28.82 to 42.96
|
29.7 pmol/10^6 cells
Interval 22.09 to 45.77
|
PRIMARY outcome
Timeframe: Day 12 of dosingTo compare 3TC- triphosphate concentrations in HIV-negative versus HIV-infected subjects.
Outcome measures
| Measure |
HIV-negative
n=20 Participants
This group was used to compare intracellular ZDV-triphosphate concentrations to the HIV-infected group
zidovudine 300mg twice daily for 12 days in the HIV-negative group
|
HIV-infected
n=23 Participants
This group was used to compare intracellular ZDV-triphosphate concentrations to the HIV-infected group
zidovudine 300mg twice daily for 12 days in the HIV-negative group
|
|---|---|---|
|
3TC-TP Drug Levels Compared Between HIV Negative and HIV Infected Subject
|
7.25 pmol/10^6 cells
Interval 6.02 to 8.05
|
5.3 pmol/10^6 cells
Interval 4.37 to 6.15
|
Adverse Events
HIV-negative
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
HIV-infected
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HIV-negative
n=20 participants at risk
This group was used to compare intracellular ZDV- and 3TC-triphosphate concentrations to the HIV-infected group and in men versus women.
zidovudine 300mg and lamivudine 150mg as Combivir: twice daily for 12 days in the HIV-negative group
|
HIV-infected
n=23 participants at risk
This group was started on ZDV-3TC based therapy. Intracellular ZDV- and 3TC-triphosphate concentrations were compared in men versus women and the HIV-negative group.
zidovudine 300mg and lamivudine 150mg as Combivir: indefinitely for their care in the HIV-positive group
|
|---|---|---|
|
Hepatobiliary disorders
Abnormal lab- Bilirubin
|
35.0%
7/20 • Time of consenting to study exit (Day 12 or earlier).
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 - December 2004 (Clarification dated August 2009) (US Dept HHS, NIH, NIAID) Available from: https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf
|
34.8%
8/23 • Time of consenting to study exit (Day 12 or earlier).
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 - December 2004 (Clarification dated August 2009) (US Dept HHS, NIH, NIAID) Available from: https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf
|
|
Hepatobiliary disorders
Abnormal Lab- albumin
|
0.00%
0/20 • Time of consenting to study exit (Day 12 or earlier).
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 - December 2004 (Clarification dated August 2009) (US Dept HHS, NIH, NIAID) Available from: https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf
|
26.1%
6/23 • Time of consenting to study exit (Day 12 or earlier).
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 - December 2004 (Clarification dated August 2009) (US Dept HHS, NIH, NIAID) Available from: https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf
|
|
Hepatobiliary disorders
Abnormal Lab- Alanine Aminotransferase (ALT)
|
0.00%
0/20 • Time of consenting to study exit (Day 12 or earlier).
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 - December 2004 (Clarification dated August 2009) (US Dept HHS, NIH, NIAID) Available from: https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf
|
30.4%
7/23 • Time of consenting to study exit (Day 12 or earlier).
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 - December 2004 (Clarification dated August 2009) (US Dept HHS, NIH, NIAID) Available from: https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf
|
|
Hepatobiliary disorders
Abnormal Lab- Aspartate transaminase (AST)
|
0.00%
0/20 • Time of consenting to study exit (Day 12 or earlier).
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 - December 2004 (Clarification dated August 2009) (US Dept HHS, NIH, NIAID) Available from: https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf
|
30.4%
7/23 • Time of consenting to study exit (Day 12 or earlier).
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 - December 2004 (Clarification dated August 2009) (US Dept HHS, NIH, NIAID) Available from: https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf
|
|
Endocrine disorders
Abnormal Lab- Amylase
|
0.00%
0/20 • Time of consenting to study exit (Day 12 or earlier).
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 - December 2004 (Clarification dated August 2009) (US Dept HHS, NIH, NIAID) Available from: https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf
|
30.4%
7/23 • Time of consenting to study exit (Day 12 or earlier).
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 - December 2004 (Clarification dated August 2009) (US Dept HHS, NIH, NIAID) Available from: https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf
|
|
Gastrointestinal disorders
Nausea, Vomiting, and/or Diarrhea
|
20.0%
4/20 • Time of consenting to study exit (Day 12 or earlier).
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 - December 2004 (Clarification dated August 2009) (US Dept HHS, NIH, NIAID) Available from: https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf
|
4.3%
1/23 • Time of consenting to study exit (Day 12 or earlier).
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 - December 2004 (Clarification dated August 2009) (US Dept HHS, NIH, NIAID) Available from: https://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf
|
Additional Information
Dr. Peter Anderson
University of Colorado | Skaggs School of Pharmacy and Pharmaceutical Sciences
Phone: 3037246128
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place