Trial Outcomes & Findings for Switching From Efavirenz to Atazanavir/ Ritonavir in HIV-infected Subjects With Good Virologic Suppression (NCT NCT01194856)
NCT ID: NCT01194856
Last Updated: 2017-08-11
Results Overview
To examine the effect of switching from EFV- to ATV/r on limb fat in HIV-1 infected patients with established lipoatrophy, the primary objective of this trial will be to compare changes over 48 weeks in DEXA-measured limb fat between the EFV arm and ATV/r.
TERMINATED
PHASE4
1 participants
48 weeks
2017-08-11
Participant Flow
Participant milestones
| Measure |
Efavirenz 600 mg
Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen
Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks
|
Arm B - Atazanavir/Ritonavir
Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks
Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Switching From Efavirenz to Atazanavir/ Ritonavir in HIV-infected Subjects With Good Virologic Suppression
Baseline characteristics by cohort
| Measure |
Efavirenz 600 mg
n=1 Participants
Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen
Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks
|
Arm B - Atazanavir/Ritonavir
Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks
Atazanavir/ritonavir: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Data not collected for analysis due to low enrollment and participant discontinuation.
To examine the effect of switching from EFV- to ATV/r on limb fat in HIV-1 infected patients with established lipoatrophy, the primary objective of this trial will be to compare changes over 48 weeks in DEXA-measured limb fat between the EFV arm and ATV/r.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 96 weeksPopulation: Data not collected for analysis due to low enrollment and participant discontinuation.
To examine the effect of switching from EFV- to ATV/r on limb fat in HIV-1 infected patients with established lipoatrophy, a secondary objective of this trial will be to compare changes over 96 weeks in DEXA-measured limb fat between the EFV arm and ARV/r.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 96 weeksPopulation: Data not collected for analysis due to low enrollment and participant discontinuation.
To examine the effect of switching from EFV to ATV/r on safety in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in CD4 cell count, HIV-1 RNA levels, and adverse events between the EFV arm and the ATV/r arm
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 96 weeksPopulation: Data not collected for analysis due to low enrollment and participant discontinuation.
To examine the effect of switching from EFV to ATV/r on fat mtDNA, mtRNA, and fat apoptosis in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in fat mtDNA, mt RNA levels and fat apoptosis between the EFV arm and ARV/r arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 96 weeksPopulation: Data not collected for analysis due to low enrollment and participant discontinuation.
To examine the effect of switching from EFV to ATV/r on lipids in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in fasting lipid levels between the EFV arm and ATV/r arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 96 weeksPopulation: Data not collected for analysis due to low enrollment and participant discontinuation.
To examine the effect of switching from EFV to ATV/r on glucose metabolism in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in fasting insulin, QUIKI and HOMA-IR between the EFV arm and the ATV/r arm
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 96 weeksPopulation: Data not collected for analysis due to low enrollment and participant discontinuation.
To examine the effect of switching from EFV to ATV/r on highly sensitive C-reactive protein (hs-CRP) in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in hs (highly sensitive) - CRP levels between the EFV arm and the ATV/r arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 96 weeksPopulation: Data not collected for analysis due to low enrollment and participant discontinuation.
A secondary objective of this trial will be to correlate the changes in DEXA-measured limb fat with those of fat mtDNA, mtRNA levels and fat apoptosis
Outcome measures
Outcome data not reported
Adverse Events
Efavirenz 600 mg
Arm B - Atazanavir/Ritonavir
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place