Trial Outcomes & Findings for Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects (NCT NCT00960622)

Last Updated: 2013-03-04

Results Overview

change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2013-03-04

Participant Flow

Subjects were recruited from clinics.

Subjects had to take combivir or trizivir for at least 6 months prior to enrollment

Participant milestones

Participant milestones
Measure	Truvada 200/300 mg, Daily, by Mouth. The study subjects will be randomly assigned to switch from Combivir or from trizivir to open-label Truvada.	Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily. The study subjects will be randomly assigned to continue on Combivir or trizivir.This will serve as comparator group.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	7
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Truvada n=10 Participants switch from Combivir to Truvada	Combivir, Trizivir. n=10 Participants continue on Combivir, trizivir.	Total n=20 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	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	52 years STANDARD_DEVIATION 6 • n=5 Participants	53 years STANDARD_DEVIATION 4 • n=7 Participants	53 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Outcome measures

Outcome measures
Measure	Truvada 200/300 mg, Daily, by Mouth. n=10 Participants switch from Combivir or trizivir to Truvada 200/300 mg, daily, by mouth.	Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily. n=10 Participants continue on Combivir 150/300 mg, or trizivir 300/150/300 mg daily.
Change in Peak Oxygen Uptake.	2.2 ml/Kg/min Standard Deviation 8.5	2.8 ml/Kg/min Standard Deviation 3.3

Adverse Events

Truvada

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combivir, Trizivir.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Donald Phillip Kotler

St Luke's Roosevelt Hospital New York

Phone: 212 523 3670

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place