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Trial record 2 of 3106 for:    HIV Infections | NIH

Drug Treatment Combined With Drug and Risk Reduction Counseling to Prevent of HIV Infection and Death Among Injection Drug Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00270257
Recruitment Status : Terminated (DSMB halted the study due to futility as a result of lower than anticipated HIV incidence rates)
First Posted : December 26, 2005
Results First Posted : December 8, 2016
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions HIV Infections
Opioid-Related Disorders
Intervention Drug: Buprenorphine/Naloxone
Enrollment 1251
Recruitment Details

The sites were selected based on prior HIV incidence rates among opiate injectors.

At the first scheduled interim analyses, when 25% of the participants had completed 104 weeks on study, the Data Safety Monitoring Board (DSMB) halted the study due to futility as a result of lower than anticipated HIV incidence rates.

Pre-assignment Details The study represented the first use of buprenorphine-naloxone as a treatment for opiate dependence in each community, thus implementation of the study and recruitment of participants included a significant effort devoted to community engagement and education. Each site had an active community advisory board (CAB).
Arm/Group Title Long Term Medication Assisted Treatment (LT-MAT) Short Term Medication Assisted Treatment (ST-MAT)
Hide Arm/Group Description

Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52

Buprenorphine/Naloxone: Oral tablet

Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.

Buprenorphine/Naloxone: Oral tablet

Period Title: Overall Study
Started 623 628 [1]
Week 8 510 443
Week 26 460 440
Week 52 362 340
Week 78 283 285
Visit 104 211 204
Completed 211 204
Not Completed 412 424
Reason Not Completed
Data Safety Monitoring Board (DSMB) halt             412             424
[1]
1 excluded from analysis (enrollment date exceeded eligibility window by 13 days)
Arm/Group Title Long Term Medication Assisted Treatment (LT-MAT) Short Term Medication Assisted Treatment (ST-MAT) Total
Hide Arm/Group Description

Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52

Buprenorphine/Naloxone: Oral tablet

Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.

Buprenorphine/Naloxone: Oral tablet

Total of all reporting groups
Overall Number of Baseline Participants 623 627 1250
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 623 participants 627 participants 1250 participants
33
(27 to 39)
34
(28 to 39)
34
(28 to 39)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 623 participants 627 participants 1250 participants
Female
49
   7.9%
50
   8.0%
99
   7.9%
Male
574
  92.1%
577
  92.0%
1151
  92.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 623 participants 627 participants 1250 participants
China 522 527 1049
Thailand 101 100 201
Years of Injection  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 623 participants 627 participants 1250 participants
7
(3 to 12)
7
(3 to 12)
7
(3 to 12)
1.Primary Outcome
Title Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks
Time Frame For visits up to week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Data Safety Monitoring Board (DSMB) halted the study on October 4, 2011 due to futility as a result of lower than anticipated HIV incidence rates. See participant flow section for the number of participants who completed visit up to 104 by July 31, 2012.
Arm/Group Title Long Term Medication Assisted Treatment (LT-MAT) Short Term Medication Assisted Treatment (ST-MAT)
Hide Arm/Group Description:

Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52

Buprenorphine/Naloxone: Oral tablet

Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.

Buprenorphine/Naloxone: Oral tablet

Overall Number of Participants Analyzed 477 470
Measure Type: Number
Unit of Measure: participants
# of HIV infections 2 5
# of Deaths 8 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long Term Medication Assisted Treatment (LT-MAT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident rate per 100 person-years
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
0.7 to 2.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Short Term Medication Assisted Treatment (ST-MAT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident rate per 100 person-years
Estimated Value 2.2
Confidence Interval (2-Sided) 95%
1.2 to 3.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Long Term Medication Assisted Treatment (LT-MAT), Short Term Medication Assisted Treatment (ST-MAT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3769
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.694
Confidence Interval (2-Sided) 95%
0.308 to 1.562
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Urinalysis Results Positive for Opiates
Hide Description Urine drug screen were assessed monthly and semiannually.
Time Frame Measured through Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants presented here applies to visit 104 for whom data available.
Arm/Group Title Long Term Medication Assisted Treatment (LT-MAT) Short Term Medication Assisted Treatment (ST-MAT)
Hide Arm/Group Description:

Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52

Buprenorphine/Naloxone: Oral tablet

Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.

Buprenorphine/Naloxone: Oral tablet

Overall Number of Participants Analyzed 208 202
Measure Type: Number
Unit of Measure: participants
138 141
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long Term Medication Assisted Treatment (LT-MAT), Short Term Medication Assisted Treatment (ST-MAT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4325
Comments P value applies for the comparison at visit 104.
Method Regression, Logistic
Comments adjusted for site
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.844
Confidence Interval (2-Sided) 95%
0.553 to 1.289
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Self-report of Continued Injection Opiate Use in the Last 30 Days
Hide Description All participants completed interviewer-administered assessments of injection and non-injection drug use at baseline and at semi-annual visits.
Time Frame Measured through Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants presented here applies to whom data available at week 104.
Arm/Group Title Long Term Medication Assisted Treatment (LT-MAT) Short Term Medication Assisted Treatment (ST-MAT)
Hide Arm/Group Description:

Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52

Buprenorphine/Naloxone: Oral tablet

Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.

Buprenorphine/Naloxone: Oral tablet

Overall Number of Participants Analyzed 208 202
Measure Type: Number
Unit of Measure: participants
102 107
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long Term Medication Assisted Treatment (LT-MAT), Short Term Medication Assisted Treatment (ST-MAT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2749
Comments P value applies for the comparison at visit 104 only.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.800
Confidence Interval (2-Sided) 95%
0.536 to 1.194
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months
Hide Description [Not Specified]
Time Frame Measured through Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants presented here applies to whom data available at week 104.
Arm/Group Title Long Term Medication Assisted Treatment (LT-MAT) Short Term Medication Assisted Treatment (ST-MAT)
Hide Arm/Group Description:

Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52

Buprenorphine/Naloxone: Oral tablet

Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.

Buprenorphine/Naloxone: Oral tablet

Overall Number of Participants Analyzed 208 202
Measure Type: Number
Unit of Measure: participants
23 28
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long Term Medication Assisted Treatment (LT-MAT), Short Term Medication Assisted Treatment (ST-MAT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3446
Comments Analysis is done for visit 104
Method Regression, Logistic
Comments Adjusted for site
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.746
Confidence Interval (2-Sided) 95%
0.407 to 1.369
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Self-reported Number of Injections in the Last Month
Hide Description [Not Specified]
Time Frame Measured through Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants presented here applies to whom data available at week 104.
Arm/Group Title Long Term Medication Assisted Treatment (LT-MAT) Short Term Medication Assisted Treatment (ST-MAT)
Hide Arm/Group Description:

Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52

Buprenorphine/Naloxone: Oral tablet

Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.

Buprenorphine/Naloxone: Oral tablet

Overall Number of Participants Analyzed 623 627
Median (Inter-Quartile Range)
Unit of Measure: injections
30
(6 to 60)
30
(7 to 60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long Term Medication Assisted Treatment (LT-MAT), Short Term Medication Assisted Treatment (ST-MAT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3620
Comments P value applies for the comparison at visit 104 only. See the estimation comments for the other visits
Method Generalized linear model
Comments adjusted for site.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.8712
Confidence Interval (2-Sided) 95%
0.6477 to 1.1718
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Incident Hepatitis C Infections for Thailand and China
Hide Description

HCV antibody using two different HCV EIA assays (Ortho HCV antibody version 3.0 and Wantai HCV antibody assay) at baseline and between 26-156 weeks later.

If both HCV EIA antibody assays were nonreactive, then the participant was considered not to be HCV infected. If either assay was reactive, then the Ortho HCV assay was repeated in duplicate. If two of 3 Ortho HCV assays were reactive, then the participant was considered to be HCV infected. Samples that were repeatedly reactive for HCV antibody at a follow-up visit were tested for HCV RNA by the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV assay. Not all participants had follow-up testing performed in China due to early closure of the study by the Data Safety Monitoring Board on account of futility due to a low HIV incidence (the primary study endpoint).

Analysis was done separately for both countries

Time Frame Measured through week 156 in Thailand and 104 weeks in China
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline HCV antibody negative participants.
Arm/Group Title China Thailand
Hide Arm/Group Description:
Long Term and Short arms were compared
Long Term and Short arms were compared
Overall Number of Participants Analyzed 132 78
Measure Type: Number
Unit of Measure: participants with HCV antibody
41 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection China
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident rate of 100 person-years
Estimated Value 22
Confidence Interval (2-Sided) 95%
14.7 to 31.6
Estimation Comments 29 events over 132 person-years
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Thailand
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident rate of 100 person-years
Estimated Value 4.59
Confidence Interval (2-Sided) 95%
2.0 to 9.0
Estimation Comments 8 events over 174 person-years
7.Secondary Outcome
Title Incident Hepatitis B Infections
Hide Description Serum samples were tested at baseline and between 26-52 weeks later for Hepatitis B surface antigen (HBsAg) using a commercial enzyme immunoassay (EIA) (Abbott Murex HBsAg version 3.0). If the HBsAg test was initially non-reactive, then the participant was considered to be negative for HBsAg. If the HBsAg test was initially reactive, then it was repeated in duplicate. If at least two of 3 tests were reactive, then the participant was considered to be positive for HBsAg.
Time Frame Measured through week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title China Thailand
Hide Arm/Group Description:
Long Term and Short arms were compared
Long Term and Short arms were compared
Overall Number of Participants Analyzed 607 55
Measure Type: Number
Unit of Measure: participants with HBsAg
9 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection China
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident rate of 100 person-years
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
1.22 to 5.08
Estimation Comments 9 events over 336 person-years
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Thailand
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident rate of 100 person-years
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
0.00 to 10.1
Estimation Comments 0 events over 37 person-years
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Long Term Medication Assisted Treatment (LT-MAT) Short Term Medication Assisted Treatment (ST-MAT)
Hide Arm/Group Description

Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52

Buprenorphine/Naloxone: Oral tablet

Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.

Buprenorphine/Naloxone: Oral tablet

All-Cause Mortality
Long Term Medication Assisted Treatment (LT-MAT) Short Term Medication Assisted Treatment (ST-MAT)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Long Term Medication Assisted Treatment (LT-MAT) Short Term Medication Assisted Treatment (ST-MAT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/623 (6.10%)      42/628 (6.69%)    
Cardiac disorders     
Aortic valve incompetence   0/623 (0.00%)  0 1/628 (0.16%)  1
Cardiac failure   0/623 (0.00%)  0 1/628 (0.16%)  1
Cardiopulmonary failure   1/623 (0.16%)  1 0/628 (0.00%)  0
Myocardial infarction   1/623 (0.16%)  1 0/628 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain   1/623 (0.16%)  1 0/628 (0.00%)  0
Food poisoning   0/623 (0.00%)  0 1/628 (0.16%)  1
Gastrointestinal disorder   0/623 (0.00%)  0 1/628 (0.16%)  1
General disorders     
Death   3/623 (0.48%)  3 1/628 (0.16%)  1
Drowning   0/623 (0.00%)  0 1/628 (0.16%)  1
Infections and infestations     
Appendicitis   1/623 (0.16%)  1 0/628 (0.00%)  0
Bone tuberculosis   0/623 (0.00%)  0 1/628 (0.16%)  1
Gastroenteritis   0/623 (0.00%)  0 1/628 (0.16%)  1
Neurocysticercosis   0/623 (0.00%)  0 1/628 (0.16%)  1
Osteomyelitis   1/623 (0.16%)  1 0/628 (0.00%)  0
Penicilliosis   0/623 (0.00%)  0 1/628 (0.16%)  1
Pneumonia   1/623 (0.16%)  1 2/628 (0.32%)  2
Pneumonia staphylococcal   1/623 (0.16%)  1 0/628 (0.00%)  0
Pulmonary tuberculosis   1/623 (0.16%)  1 0/628 (0.00%)  0
Sepsis   0/623 (0.00%)  0 1/628 (0.16%)  1
Septic shock   0/623 (0.00%)  0 1/628 (0.16%)  1
Staphylococcal bacteraemia   0/623 (0.00%)  0 1/628 (0.16%)  1
Subcutaneous abscess   0/623 (0.00%)  0 1/628 (0.16%)  1
Tuberculous pleurisy   2/623 (0.32%)  2 0/628 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture   1/623 (0.16%)  1 0/628 (0.00%)  0
Cerebral haemorrhage traumatic   1/623 (0.16%)  1 0/628 (0.00%)  0
Concussion   1/623 (0.16%)  1 0/628 (0.00%)  0
Craniocerebral injury   0/623 (0.00%)  0 1/628 (0.16%)  1
Fibula fracture   0/623 (0.00%)  0 1/628 (0.16%)  1
Foot fracture   0/623 (0.00%)  0 2/628 (0.32%)  2
Head injury   0/623 (0.00%)  0 1/628 (0.16%)  1
Lower limb fracture   1/623 (0.16%)  1 0/628 (0.00%)  0
Overdose   3/623 (0.48%)  3 5/628 (0.80%)  5
Pelvic fracture   1/623 (0.16%)  1 0/628 (0.00%)  0
Stab wound   1/623 (0.16%)  1 0/628 (0.00%)  0
Investigations     
Alanine aminotransferase increased   12/623 (1.93%)  12 14/628 (2.23%)  14
Blood bilirubin increased   1/623 (0.16%)  1 0/628 (0.00%)  0
Platelet count decreased  0/623 (0.00%)  0 1/628 (0.16%)  1
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion   1/623 (0.16%)  1 0/628 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric cancer   1/623 (0.16%)  1 0/628 (0.00%)  0
Hepatic neoplasm malignant   0/623 (0.00%)  0 1/628 (0.16%)  1
Nervous system disorders     
Loss of consciousness   1/623 (0.16%)  1 0/628 (0.00%)  0
Subarachnoid haemorrhage   1/623 (0.16%)  1 0/628 (0.00%)  0
Psychiatric disorders     
Depression   1/623 (0.16%)  1 0/628 (0.00%)  0
Personality disorder   1/623 (0.16%)  1 0/628 (0.00%)  0
Suicide attempt   1/623 (0.16%)  1 0/628 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pleural effusion   0/623 (0.00%)  0 1/628 (0.16%)  1
Skin and subcutaneous tissue disorders     
Henoch−Schonlein purpura   1/623 (0.16%)  1 0/628 (0.00%)  0
Vascular disorders     
Vascular rupture   0/623 (0.00%)  0 1/628 (0.16%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Long Term Medication Assisted Treatment (LT-MAT) Short Term Medication Assisted Treatment (ST-MAT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/623 (0.00%)      1/628 (0.16%)    
Injury, poisoning and procedural complications     
chest Injury   0/623 (0.00%)  0 1/628 (0.16%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All study abstracts and publications are subject to HPTN Publication and Public Information Policies and Clinical Trial Agreements between NIAID (DAIDS) and company collaborators. The publication or other disclosure can be delayed for up to thirty additional business days for manuscripts & five business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Results Point of Contact
Name/Title: Senior Statistical Analyst
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-667-6167
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00270257     History of Changes
Other Study ID Numbers: HPTN 058
10144 ( Registry Identifier: DAIDS ES )
First Submitted: December 22, 2005
First Posted: December 26, 2005
Results First Submitted: November 5, 2015
Results First Posted: December 8, 2016
Last Update Posted: February 2, 2017