Trial Outcomes & Findings for Studies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT) (NCT NCT00000142)
NCT ID: NCT00000142
Last Updated: 2015-11-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
64 participants
Primary outcome timeframe
All patients enrolled will be followed until a common study closing date
Results posted on
2015-11-17
Participant Flow
April 1994
Participant milestones
| Measure |
Treatment Deferral
IV (in the vein) treatment deferred until retinitis progressed, either:
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
1. the deferral group, treatment deferred until retinitis progressed
2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
Cidofovir (Low Dose)
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks
Cidofovir: Three groups:
1. the deferral group, treatment deferred until retinitis progressed
2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
Cidofovir (High Dose)
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
1. the deferral group, treatment deferred until retinitis progressed
2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
12
|
|
Overall Study
COMPLETED
|
26
|
26
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Studies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT)
Baseline characteristics by cohort
| Measure |
Treatment Deferral
n=26 Participants
IV (in the vein) treatment deferred until retinitis progressed, either:
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
1. the deferral group, treatment deferred until retinitis progressed
2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
Cidofovir (Low Dose)
n=26 Participants
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks
Cidofovir: Three groups:
1. the deferral group, treatment deferred until retinitis progressed
2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
Cidofovir (High Dose)
n=12 Participants
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
1. the deferral group, treatment deferred until retinitis progressed
2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: All patients enrolled will be followed until a common study closing dateOutcome measures
| Measure |
Treatment Deferral
n=26 Participants
IV (in the vein) treatment deferred until retinitis progressed, either:
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
1. the deferral group, treatment deferred until retinitis progressed
2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
Cidofovir (Low Dose)
n=26 Participants
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks
Cidofovir: Three groups:
1. the deferral group, treatment deferred until retinitis progressed
2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
Cidofovir (High Dose)
n=12 Participants
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
1. the deferral group, treatment deferred until retinitis progressed
2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
|---|---|---|---|
|
Survival
mortality
|
6 participants
|
7 participants
|
3 participants
|
|
Survival
progression
|
20 participants
|
17 participants
|
5 participants
|
|
Survival
va loss of 15 letters
|
4 participants
|
6 participants
|
2 participants
|
Adverse Events
Treatment Deferral
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Cidofovir (Low Dose)
Serious events: 13 serious events
Other events: 2 other events
Deaths: 0 deaths
Cidofovir (High Dose)
Serious events: 8 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Deferral
n=26 participants at risk
IV (in the vein) treatment deferred until retinitis progressed, either:
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
1. the deferral group, treatment deferred until retinitis progressed
2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
Cidofovir (Low Dose)
n=26 participants at risk
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks
Cidofovir: Three groups:
1. the deferral group, treatment deferred until retinitis progressed
2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
Cidofovir (High Dose)
n=12 participants at risk
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
1. the deferral group, treatment deferred until retinitis progressed
2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Proteinuria 2+
|
11.5%
3/26 • Number of events 4 • 1 year, 10 months
|
50.0%
13/26 • Number of events 21 • 1 year, 10 months
|
66.7%
8/12 • Number of events 25 • 1 year, 10 months
|
Other adverse events
| Measure |
Treatment Deferral
n=26 participants at risk
IV (in the vein) treatment deferred until retinitis progressed, either:
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
1. the deferral group, treatment deferred until retinitis progressed
2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
Cidofovir (Low Dose)
n=26 participants at risk
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks
Cidofovir: Three groups:
1. the deferral group, treatment deferred until retinitis progressed
2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
Cidofovir (High Dose)
n=12 participants at risk
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
1. the deferral group, treatment deferred until retinitis progressed
2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Serum creatinine level >= 133 umol/L (1.5 mg/dL)
|
0.00%
0/26 • 1 year, 10 months
|
7.7%
2/26 • Number of events 2 • 1 year, 10 months
|
16.7%
2/12 • Number of events 2 • 1 year, 10 months
|
Additional Information
Dr. Curtis Meinert
Johns Hopkins Bloomberg School of Public Health
Phone: 410-955-8175
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60