Trial Outcomes & Findings for Trial to Assess the Impact of PrEP to Tenofovir Gel on the Efficacy of Tenofovir-containing ART on Viral Suppression (NCT NCT01387022)
NCT ID: NCT01387022
Last Updated: 2017-04-20
Results Overview
Treatment failure is defined as viral load \> 50 copies/ml, antiretroviral regimen changes for treatment failure or death
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
12 months post ART intiation or until time of death
Results posted on
2017-04-20
Participant Flow
Two arm, open-label, randomised controlled trial
A total of 214 participants were assessed for eligibility: 60 were excluded due to high CD4+ count, 30 were already on ART, 8 were loss to follow-up and 43 refused participation. Of the 73 that were screened, 8 were screen failures due to high CD4+ count, 4 refused participation, 1 was very ill with TB and 1 could not be contacted.
Participant milestones
| Measure |
Tenofovir-containing Regimen
Patients were initiated on EFV, FTC/3TC,TDF
|
Tenofovir-sparing Regimen
Patients were initiated on EFV,FTC/3TC,ZDV
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
COMPLETED
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Tenofovir-containing Regimen
Patients were initiated on EFV, FTC/3TC,TDF
|
Tenofovir-sparing Regimen
Patients were initiated on EFV,FTC/3TC,ZDV
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
Baseline Characteristics
Trial to Assess the Impact of PrEP to Tenofovir Gel on the Efficacy of Tenofovir-containing ART on Viral Suppression
Baseline characteristics by cohort
| Measure |
Tenofovir-containing Regimen
n=29 Participants
Patients were initiated on EFV, FTC/3TC,TDF
|
Tenofovir-sparing Regimen
n=30 Participants
Patients were initiated on EFV,FTC/3TC,ZDV
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 years
n=99 Participants
|
28 years
n=107 Participants
|
28 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
29 participants
n=99 Participants
|
30 participants
n=107 Participants
|
59 participants
n=206 Participants
|
|
CD4+ T cell count
|
345 cells/uL
n=99 Participants
|
335 cells/uL
n=107 Participants
|
345 cells/uL
n=206 Participants
|
|
Viral load
|
4.4 log10 copies/ml
STANDARD_DEVIATION 0.79 • n=99 Participants
|
4.6 log10 copies/ml
STANDARD_DEVIATION 0.80 • n=107 Participants
|
4.5 log10 copies/ml
STANDARD_DEVIATION 0.79 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 months post ART intiation or until time of deathPopulation: All participants who randomised and initiated on ART
Treatment failure is defined as viral load \> 50 copies/ml, antiretroviral regimen changes for treatment failure or death
Outcome measures
| Measure |
Tenofovir-containing Regimen
n=29 Participants
Patients were initiated on EFV, FTC/3TC,TDF
|
Tenofovir-sparing Regimen
n=30 Participants
Patients were initiated on EFV,FTC/3TC,ZDV
|
|---|---|---|
|
The Antiretroviral Treatment Failure Rate at 12 Months.
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Measured at 12 months post ART initiationPopulation: All participants for whom CD4+ count measurements were recorded at randomisation and at 12 months
Difference between 12 months and randomisation CD4+ count was calculated and then summarised
Outcome measures
| Measure |
Tenofovir-containing Regimen
n=21 Participants
Patients were initiated on EFV, FTC/3TC,TDF
|
Tenofovir-sparing Regimen
n=19 Participants
Patients were initiated on EFV,FTC/3TC,ZDV
|
|---|---|---|
|
Change in CD4+ Cell Count From Randomisation to 12 Months Post-randomisation
|
217 cells/uL
Interval 52.0 to 272.0
|
174 cells/uL
Interval 70.0 to 404.0
|
SECONDARY outcome
Timeframe: From randomisation until either time of termination or time of deathPopulation: Resistance testing was only done on participants who were failing first line antiretroviral therapy.
Outcome measures
| Measure |
Tenofovir-containing Regimen
n=1 Participants
Patients were initiated on EFV, FTC/3TC,TDF
|
Tenofovir-sparing Regimen
n=1 Participants
Patients were initiated on EFV,FTC/3TC,ZDV
|
|---|---|---|
|
Tenofovir Resistance, Defined as Presence of K65R, K70E or Any of the TAMS Mutations
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From randomisation until either time of termination or time of deathPopulation: All participants who randomised and initiated on ART
Outcome measures
| Measure |
Tenofovir-containing Regimen
n=29 Participants
Patients were initiated on EFV, FTC/3TC,TDF
|
Tenofovir-sparing Regimen
n=30 Participants
Patients were initiated on EFV,FTC/3TC,ZDV
|
|---|---|---|
|
Reported Adverse Events With Severity Grades 3 and 4 Based on the DAIDS Toxicity Grading Tables
|
7 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Data were not collected for this Outcome Measure
We will assess whether exposure to tenofovir gel at the time of HIV acquisition alters the subsequent humoral and cellular immune responses following antiretroviral treatment initiation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: Data were not collected for this Outcome Measure
Outcome measures
Outcome data not reported
Adverse Events
Tenofovir-containing Regimen
Serious events: 10 serious events
Other events: 1 other events
Deaths: 0 deaths
Tenofovir-sparing Regimen
Serious events: 11 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tenofovir-containing Regimen
n=29 participants at risk
Patients were initiated on EFV, FTC/3TC,TDF
|
Tenofovir-sparing Regimen
n=30 participants at risk
Patients were initiated on EFV,FTC/3TC,ZDV
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 1 • 19 July 2011 to 30 September 2014
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 1 • 19 July 2011 to 30 September 2014
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 1 • 19 July 2011 to 30 September 2014
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 1 • 19 July 2011 to 30 September 2014
|
|
General disorders
Malaise
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 1 • 19 July 2011 to 30 September 2014
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 1 • 19 July 2011 to 30 September 2014
|
|
Infections and infestations
Pelvic inflammatory disease
|
3.4%
1/29 • Number of events 1 • 19 July 2011 to 30 September 2014
|
0.00%
0/30 • 19 July 2011 to 30 September 2014
|
|
Metabolism and nutrition disorders
Hyperlactacidaemia
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 2 • 19 July 2011 to 30 September 2014
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hydatidiform mole
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 1 • 19 July 2011 to 30 September 2014
|
|
Nervous system disorders
Headache
|
3.4%
1/29 • Number of events 1 • 19 July 2011 to 30 September 2014
|
0.00%
0/30 • 19 July 2011 to 30 September 2014
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 1 • 19 July 2011 to 30 September 2014
|
|
Pregnancy, puerperium and perinatal conditions
Delivery
|
17.2%
5/29 • Number of events 5 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 1 • 19 July 2011 to 30 September 2014
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
3.4%
1/29 • Number of events 1 • 19 July 2011 to 30 September 2014
|
0.00%
0/30 • 19 July 2011 to 30 September 2014
|
|
Psychiatric disorders
Completed suicide
|
3.4%
1/29 • Number of events 1 • 19 July 2011 to 30 September 2014
|
0.00%
0/30 • 19 July 2011 to 30 September 2014
|
|
Surgical and medical procedures
Abscess drainage
|
3.4%
1/29 • Number of events 1 • 19 July 2011 to 30 September 2014
|
0.00%
0/30 • 19 July 2011 to 30 September 2014
|
|
Surgical and medical procedures
Caesarean section
|
6.9%
2/29 • Number of events 2 • 19 July 2011 to 30 September 2014
|
10.0%
3/30 • Number of events 3 • 19 July 2011 to 30 September 2014
|
|
Surgical and medical procedures
Female sterilisation
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 1 • 19 July 2011 to 30 September 2014
|
Other adverse events
| Measure |
Tenofovir-containing Regimen
n=29 participants at risk
Patients were initiated on EFV, FTC/3TC,TDF
|
Tenofovir-sparing Regimen
n=30 participants at risk
Patients were initiated on EFV,FTC/3TC,ZDV
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 1 • 19 July 2011 to 30 September 2014
|
|
Infections and infestations
Bartholin's abscess
|
3.4%
1/29 • Number of events 1 • 19 July 2011 to 30 September 2014
|
0.00%
0/30 • 19 July 2011 to 30 September 2014
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
6.7%
2/30 • Number of events 2 • 19 July 2011 to 30 September 2014
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 1 • 19 July 2011 to 30 September 2014
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 1 • 19 July 2011 to 30 September 2014
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 1 • 19 July 2011 to 30 September 2014
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
3.3%
1/30 • Number of events 1 • 19 July 2011 to 30 September 2014
|
|
Psychiatric disorders
Depression
|
0.00%
0/29 • 19 July 2011 to 30 September 2014
|
6.7%
2/30 • Number of events 2 • 19 July 2011 to 30 September 2014
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place