Trial Outcomes & Findings for Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection (NCT NCT00414518)
NCT ID: NCT00414518
Last Updated: 2013-02-20
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
At Week 24
Results posted on
2013-02-20
Participant Flow
Participant milestones
| Measure |
Treatment Interruption
Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm\^3 or higher. When CD4 count is less than 350 mm\^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
|
CD4 T Cell Guided Therapy
Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm\^3 at two separate, consecutive measurements
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection
Baseline characteristics by cohort
| Measure |
Arm A
n=7 Participants
Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm\^3 or higher. When CD4 count is less than 350 mm\^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
|
Arm B
n=9 Participants
Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm\^3 at two separate, consecutive measurements
|
Total
n=16 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
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 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
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Zimbabwe
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 24Outcome measures
| Measure |
12 Week Treatment Arm Followed by Treatment Interruption
n=7 Participants
Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm\^3 or higher. When CD4 count is less than 350 mm\^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
|
CD4 T Cell Guided Therapyh
n=9 Participants
Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm\^3 at two separate, consecutive measurements
|
|---|---|---|
|
Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms
|
4.8627 Log 10 copies of virus/ml
Standard Deviation 0.9055 • Interval to 1.5
|
4.2620 Log 10 copies of virus/ml
Standard Deviation 1.0867 • Interval to 1.37
|
PRIMARY outcome
Timeframe: At Week 24Outcome measures
| Measure |
12 Week Treatment Arm Followed by Treatment Interruption
n=7 Participants
Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm\^3 or higher. When CD4 count is less than 350 mm\^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
|
CD4 T Cell Guided Therapyh
n=9 Participants
Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm\^3 at two separate, consecutive measurements
|
|---|---|---|
|
Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Throughout studyset point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus
Outcome measures
| Measure |
12 Week Treatment Arm Followed by Treatment Interruption
n=7 Participants
Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm\^3 or higher. When CD4 count is less than 350 mm\^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
|
CD4 T Cell Guided Therapyh
n=9 Participants
Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm\^3 at two separate, consecutive measurements
|
|---|---|---|
|
Viral Set Point
|
4.8627 Log 10 copies virus/ml
Standard Deviation 0.9055
|
4.2434 Log 10 copies virus/ml
Standard Deviation 0.7992
|
Adverse Events
Arm A
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm B
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=7 participants at risk
Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm\^3 or higher. When CD4 count is less than 350 mm\^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
|
Arm B
n=9 participants at risk
Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm\^3 at two separate, consecutive measurements
|
|---|---|---|
|
Metabolism and nutrition disorders
grade 3 abnormal serum phosphorous level
|
14.3%
1/7 • Number of events 2
|
0.00%
0/9
|
|
Nervous system disorders
grade 3 headache
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
Other adverse events
| Measure |
Arm A
n=7 participants at risk
Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm\^3 or higher. When CD4 count is less than 350 mm\^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
|
Arm B
n=9 participants at risk
Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm\^3 at two separate, consecutive measurements
|
|---|---|---|
|
Blood and lymphatic system disorders
low absolute neutrophil count (ANC)
|
42.9%
3/7 • Number of events 3
|
44.4%
4/9 • Number of events 4
|
|
Metabolism and nutrition disorders
Elevated aspartate amino transferase
|
14.3%
1/7 • Number of events 1
|
55.6%
5/9 • Number of events 5
|
|
Blood and lymphatic system disorders
abnormal hemoglobin
|
14.3%
1/7 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
abnormal phosphorus
|
0.00%
0/7
|
22.2%
2/9 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
ache/pain/discomfort
|
28.6%
2/7 • Number of events 2
|
44.4%
4/9 • Number of events 4
|
|
Metabolism and nutrition disorders
abnormal alanine amino transferase
|
14.3%
1/7 • Number of events 1
|
33.3%
3/9 • Number of events 3
|
|
Endocrine disorders
abnormal glucose
|
42.9%
3/7 • Number of events 3
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
fatigue/malaise
|
28.6%
2/7 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
fever
|
28.6%
2/7 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
headache
|
14.3%
1/7 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
abnormal uric acid
|
0.00%
0/7
|
33.3%
3/9 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
congestion/effusion
|
14.3%
1/7 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
lymphadenopathy
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
abnormal sodium
|
28.6%
2/7 • Number of events 2
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
blister/ulcer/lesions
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
chills/rigors/sweats/night sweats
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Endocrine disorders
abnormal fasting blood sugar
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
macules/papules/rash
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
mucous membrane/skin abnormality
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
nausea
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
nausea and vomiting/vomiting
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
weakness
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/7
|
22.2%
2/9 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place