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Trial record 1 of 1 for:    24602844 [PUBMED-IDS]
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Preventing Sexual Transmission of HIV With Anti-HIV Drugs

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ClinicalTrials.gov Identifier: NCT00074581
Recruitment Status : Completed
First Posted : December 17, 2003
Results First Posted : October 31, 2016
Last Update Posted : November 7, 2016
Sponsor:
Collaborator:
HIV Prevention Trials Network
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: Single (Participant);   Primary Purpose: Prevention
Condition HIV Infections
Interventions Drug: Atazanavir
Drug: Didanosine
Drug: Efavirenz
Drug: Emtricitabine/Tenofovir disoproxil fumarate
Drug: Lamivudine
Drug: Lopinavir/Ritonavir
Drug: Nevirapine
Drug: Stavudine
Drug: Tenofovir disoproxil fumarate
Drug: Zidovudine/Lamivudine
Enrollment 3526

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Early-ART Delayed-ART
Hide Arm/Group Description

Participants will begin ART in addition to receiving HIV primary care

Atazanavir: 300 mg taken orally once daily

Didanosine: 400 mg taken orally once daily

Efavirenz: 600 mg taken orally once daily

Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily

Lamivudine: 300 mg taken orally once daily

Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily

Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily

Stavudine: Dosage depends on weight

Tenofovir disoproxil fumarate: 300 mg taken orally once daily

Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily

Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided.

Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.

(Same drug regimen as that described in the early-ART arm)

Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.

Period Title: Overall Study
Started 1789 [1] 1767 [2]
Completed 1545 1541
Not Completed 244 226
Reason Not Completed
Death             15             16
Withdrawal by Subject             50             49
Unable to adhere to visit schedule             13             14
Relocated             14             9
Were withdrawn by investigator             5             2
Lost to Follow-up             16             11
Ended relationship w. index participant             117             106
Other             14             19
[1]
886 HIV-infected index cases and 903 HIV-uninfected partners
[2]
877 HIV-infected index cases and 890 HIV-uninfected partners
Arm/Group Title Early-ART Delayed-ART Total
Hide Arm/Group Description

Participants will begin ART in addition to receiving HIV primary care

Atazanavir: 300 mg taken orally once daily

Didanosine: 400 mg taken orally once daily

Efavirenz: 600 mg taken orally once daily

Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily

Lamivudine: 300 mg taken orally once daily

Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily

Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily

Stavudine: Dosage depends on weight

Tenofovir disoproxil fumarate: 300 mg taken orally once daily

Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily

Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided.

Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.

(Same drug regimen as that described in the early-ART arm)

Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.

Total of all reporting groups
Overall Number of Baseline Participants 1789 1767 3556
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1789 participants 1767 participants 3556 participants
18-25 yr 300 335 635
26-40 yr 1101 1079 2180
>40 yr 388 353 741
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1789 participants 1767 participants 3556 participants
Female
877
  49.0%
860
  48.7%
1737
  48.8%
Male
912
  51.0%
907
  51.3%
1819
  51.2%
Region  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1789 participants 1767 participants 3556 participants
North or South America 293 279 572
Asia 535 528 1063
Africa 961 960 1921
1.Primary Outcome
Title Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
Hide Description incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner.
Time Frame Throughout study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early-ART Delayed-ART
Hide Arm/Group Description:

Participants will begin ART in addition to receiving HIV primary care

Atazanavir: 300 mg taken orally once daily

Didanosine: 400 mg taken orally once daily

Efavirenz: 600 mg taken orally once daily

Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily

Lamivudine: 300 mg taken orally once daily

Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily

Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily

Stavudine: Dosage depends on weight

Tenofovir disoproxil fumarate: 300 mg taken orally once daily

Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily

Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided.

Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.

(Same drug regimen as that described in the early-ART arm)

Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.

Overall Number of Participants Analyzed 903 890
Overall Number of Units Analyzed
Type of Units Analyzed: Person Years
4325 4185
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: event rate per 100 person-yr
0.07
(0.01 to 0.20)
1.03
(0.74 to 1.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early-ART, Delayed-ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
0.02 to 0.22
Estimation Comments The hazard ratio estimate presented (0.07) is a comparison of the early-ART arm (numerator) to the delayed-ART arm (denominator), thus indicating a 93% lower risk of infection among all linked partner infections, during the entire study.
2.Primary Outcome
Title All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
Hide Description All Incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm.
Time Frame Throughout study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population includes all partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases, by arm.
Arm/Group Title Early-ART Delayed-ART
Hide Arm/Group Description:

Participants will begin ART in addition to receiving HIV primary care

Atazanavir: 300 mg taken orally once daily

Didanosine: 400 mg taken orally once daily

Efavirenz: 600 mg taken orally once daily

Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily

Lamivudine: 300 mg taken orally once daily

Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily

Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily

Stavudine: Dosage depends on weight

Tenofovir disoproxil fumarate: 300 mg taken orally once daily

Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily

Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided.

Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.

(Same drug regimen as that described in the early-ART arm)

Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.

Overall Number of Participants Analyzed 903 890
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: event rate per 100 person-yr
0.44
(0.26 to 0.69)
1.41
(1.07 to 1.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early-ART, Delayed-ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
0.19 to 0.53
Estimation Comments The hazard ratio estimate presented (0.31) is a comparison of the early-ART arm (numerator) to the delayed-ART arm (denominator), thus indicating a 69% lower risk of infection among all partner infections, during the entire study.
Time Frame [Not Specified]
Adverse Event Reporting Description Only index participants were monitored for adverse events since they (and not partners) were receiving treatment drugs.
 
Arm/Group Title Early-ART Delayed-ART
Hide Arm/Group Description

Participants will begin ART in addition to receiving HIV primary care

Atazanavir: 300 mg taken orally once daily

Didanosine: 400 mg taken orally once daily

Efavirenz: 600 mg taken orally once daily

Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily

Lamivudine: 300 mg taken orally once daily

Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily

Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily

Stavudine: Dosage depends on weight

Tenofovir disoproxil fumarate: 300 mg taken orally once daily

Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily

Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided.

Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.

(Same drug regimen as that described in the early-ART arm)

Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.

All-Cause Mortality
Early-ART Delayed-ART
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Early-ART Delayed-ART
Affected / at Risk (%) Affected / at Risk (%)
Total   526/886 (59.37%)   522/877 (59.52%) 
Blood and lymphatic system disorders     
Anaemia  15/886 (1.69%)  19/877 (2.17%) 
Anaemia of pregnancy  1/886 (0.11%)  1/877 (0.11%) 
Febrile neutropenia  0/886 (0.00%)  1/877 (0.11%) 
Haemolytic anaemia  1/886 (0.11%)  0/877 (0.00%) 
Iron deficiency anaemia  1/886 (0.11%)  0/877 (0.00%) 
Leukopenia  1/886 (0.11%)  3/877 (0.34%) 
Lymphadenitis 1 [1]  0/886 (0.00%)  1/877 (0.11%) 
Lymphadenopathy  0/886 (0.00%)  1/877 (0.11%) 
Neutropenia  62/886 (7.00%)  66/877 (7.53%) 
Pancytopenia  1/886 (0.11%)  1/877 (0.11%) 
Thrombocytopenia  6/886 (0.68%)  6/877 (0.68%) 
Cardiac disorders     
Acute coronary syndrome  1/886 (0.11%)  0/877 (0.00%) 
Cardiac arrest  1/886 (0.11%)  0/877 (0.00%) 
Cardiac failure  1/886 (0.11%)  0/877 (0.00%) 
Cor pulmonale  0/886 (0.00%)  1/877 (0.11%) 
Left ventricular failure  1/886 (0.11%)  0/877 (0.00%) 
Myocardial infarction  0/886 (0.00%)  2/877 (0.23%) 
Palpitations  0/886 (0.00%)  1/877 (0.11%) 
Congenital, familial and genetic disorders     
Congenital anomaly in offspring  0/886 (0.00%)  1/877 (0.11%) 
Hydrocele  0/886 (0.00%)  1/877 (0.11%) 
Ear and labyrinth disorders     
Vertigo  2/886 (0.23%)  1/877 (0.11%) 
Vertigo positional  1/886 (0.11%)  0/877 (0.00%) 
Eye disorders     
Retinal artery occlusion  0/886 (0.00%)  1/877 (0.11%) 
Ulcerative keratitis  0/886 (0.00%)  1/877 (0.11%) 
Gastrointestinal disorders     
Abdominal hernia  0/886 (0.00%)  1/877 (0.11%) 
Abdominal pain  1/886 (0.11%)  6/877 (0.68%) 
Acute abdomen  1/886 (0.11%)  0/877 (0.00%) 
Anal ulcer  1/886 (0.11%)  0/877 (0.00%) 
Diarrhoea  9/886 (1.02%)  7/877 (0.80%) 
Diarrhoea haemorrhagic  6/886 (0.68%)  9/877 (1.03%) 
Dyspepsia  1/886 (0.11%)  1/877 (0.11%) 
Enteritis  1/886 (0.11%)  0/877 (0.00%) 
Food poisoning  1/886 (0.11%)  1/877 (0.11%) 
Gastritis  0/886 (0.00%)  2/877 (0.23%) 
Gastrointestinal haemorrhage  1/886 (0.11%)  0/877 (0.00%) 
Haemorrhoids  0/886 (0.00%)  2/877 (0.23%) 
Inguinal hernia  0/886 (0.00%)  1/877 (0.11%) 
Intestinal obstruction  2/886 (0.23%)  0/877 (0.00%) 
Mouth ulceration  1/886 (0.11%)  0/877 (0.00%) 
Nausea  2/886 (0.23%)  4/877 (0.46%) 
Pancreatitis  0/886 (0.00%)  2/877 (0.23%) 
Peptic ulcer  2/886 (0.23%)  1/877 (0.11%) 
Vomiting  3/886 (0.34%)  4/877 (0.46%) 
General disorders     
Asthenia  1/886 (0.11%)  0/877 (0.00%) 
Chest pain  0/886 (0.00%)  1/877 (0.11%) 
Death  7/886 (0.79%)  5/877 (0.57%) 
Fatigue  3/886 (0.34%)  2/877 (0.23%) 
Hyperthermia  1/886 (0.11%)  0/877 (0.00%) 
Influenza like illness  0/886 (0.00%)  1/877 (0.11%) 
Injection site pain  1/886 (0.11%)  0/877 (0.00%) 
Multi-organ failure  0/886 (0.00%)  1/877 (0.11%) 
Peripheral swelling  0/886 (0.00%)  1/877 (0.11%) 
Polyp  1/886 (0.11%)  0/877 (0.00%) 
Pyrexia  4/886 (0.45%)  5/877 (0.57%) 
Hepatobiliary disorders     
Cholelithiasis  1/886 (0.11%)  0/877 (0.00%) 
Cirrhosis alcoholic  0/886 (0.00%)  1/877 (0.11%) 
Drug-induced liver injury  1/886 (0.11%)  0/877 (0.00%) 
Hepatic cirrhosis  1/886 (0.11%)  1/877 (0.11%) 
Hepatic failure  0/886 (0.00%)  1/877 (0.11%) 
Hepatitis  4/886 (0.45%)  1/877 (0.11%) 
Hepatitis acute  1/886 (0.11%)  1/877 (0.11%) 
Hepatitis alcoholic  1/886 (0.11%)  2/877 (0.23%) 
Hepatotoxicity  6/886 (0.68%)  4/877 (0.46%) 
Hyperbilirubinaemia  37/886 (4.18%)  14/877 (1.60%) 
Liver disorder  1/886 (0.11%)  5/877 (0.57%) 
Immune system disorders     
Anaphylactic reaction  0/886 (0.00%)  1/877 (0.11%) 
Drug hypersensitivity  0/886 (0.00%)  2/877 (0.23%) 
Hypersensitivity  0/886 (0.00%)  3/877 (0.34%) 
Infections and infestations     
Abortion infected  0/886 (0.00%)  1/877 (0.11%) 
Abscess  0/886 (0.00%)  1/877 (0.11%) 
Abscess bacterial  2/886 (0.23%)  0/877 (0.00%) 
Acute sinusitis  0/886 (0.00%)  1/877 (0.11%) 
Appendicitis  1/886 (0.11%)  4/877 (0.46%) 
Appendicitis perforated  1/886 (0.11%)  0/877 (0.00%) 
Bacterial pyelonephritis  2/886 (0.23%)  0/877 (0.00%) 
Bacterial sepsis  1/886 (0.11%)  0/877 (0.00%) 
Bronchitis  0/886 (0.00%)  1/877 (0.11%) 
Cellulitis  3/886 (0.34%)  4/877 (0.46%) 
Cerebral malaria  1/886 (0.11%)  1/877 (0.11%) 
Dengue fever  1/886 (0.11%)  4/877 (0.46%) 
Diarrhoea infectious  1/886 (0.11%)  0/877 (0.00%) 
Disseminated tuberculosis  1/886 (0.11%)  2/877 (0.23%) 
Dysentery  1/886 (0.11%)  4/877 (0.46%) 
Enteritis infectious  0/886 (0.00%)  1/877 (0.11%) 
Erysipelas  1/886 (0.11%)  0/877 (0.00%) 
Extrapulmonary tuberculosis  1/886 (0.11%)  6/877 (0.68%) 
Furuncle  0/886 (0.00%)  2/877 (0.23%) 
Gastroenteritis  12/886 (1.35%)  19/877 (2.17%) 
Gastrointestinal infection  0/886 (0.00%)  2/877 (0.23%) 
H1N1 influenza  1/886 (0.11%)  0/877 (0.00%) 
Herpes zoster  2/886 (0.23%)  5/877 (0.57%) 
Herpes zoster oticus  0/886 (0.00%)  1/877 (0.11%) 
Influenza  2/886 (0.23%)  2/877 (0.23%) 
Joint abscess  0/886 (0.00%)  1/877 (0.11%) 
Leptospirosis  4/886 (0.45%)  2/877 (0.23%) 
Liver abscess  0/886 (0.00%)  1/877 (0.11%) 
Lower respiratory tract infection  1/886 (0.11%)  0/877 (0.00%) 
Lower respiratory tract infection bacterial  0/886 (0.00%)  1/877 (0.11%) 
Lymph node tuberculosis  0/886 (0.00%)  2/877 (0.23%) 
Malaria  23/886 (2.60%)  20/877 (2.28%) 
Measles  1/886 (0.11%)  0/877 (0.00%) 
Meningitis  4/886 (0.45%)  2/877 (0.23%) 
Meningitis bacterial  1/886 (0.11%)  1/877 (0.11%) 
Meningitis cryptococcal  1/886 (0.11%)  0/877 (0.00%) 
Meningitis tuberculous  0/886 (0.00%)  2/877 (0.23%) 
Meningococcal sepsis  1/886 (0.11%)  0/877 (0.00%) 
Meningoencephalitis herpetic  0/886 (0.00%)  1/877 (0.11%) 
Muscle abscess  0/886 (0.00%)  1/877 (0.11%) 
Nasal abscess  0/886 (0.00%)  1/877 (0.11%) 
Nasopharyngitis  1/886 (0.11%)  1/877 (0.11%) 
Osteomyelitis chronic  1/886 (0.11%)  0/877 (0.00%) 
Pelvic abscess  1/886 (0.11%)  0/877 (0.00%) 
Pelvic inflammatory disease  8/886 (0.90%)  6/877 (0.68%) 
Pharyngitis  0/886 (0.00%)  3/877 (0.34%) 
Pharyngitis bacterial  1/886 (0.11%)  1/877 (0.11%) 
Plasmodium falciparum infection  2/886 (0.23%)  0/877 (0.00%) 
Plasmodium malariae infection  3/886 (0.34%)  0/877 (0.00%) 
Pneumocystis jirovecii pneumonia  1/886 (0.11%)  2/877 (0.23%) 
Pneumonia  16/886 (1.81%)  11/877 (1.25%) 
Pneumonia bacterial  7/886 (0.79%)  1/877 (0.11%) 
Pneumonia viral  1/886 (0.11%)  0/877 (0.00%) 
Post procedural infection  1/886 (0.11%)  0/877 (0.00%) 
Postoperative wound infection  1/886 (0.11%)  0/877 (0.00%) 
Progressive multifocal leukoencephalopathy  0/886 (0.00%)  1/877 (0.11%) 
Pulmonary sepsis  1/886 (0.11%)  0/877 (0.00%) 
Pulmonary tuberculosis  4/886 (0.45%)  7/877 (0.80%) 
Pyelonephritis  2/886 (0.23%)  2/877 (0.23%) 
Pyelonephritis acute  2/886 (0.23%)  1/877 (0.11%) 
Respiratory tract infection  0/886 (0.00%)  2/877 (0.23%) 
Secondary syphilis  1/886 (0.11%)  0/877 (0.00%) 
Sepsis  3/886 (0.34%)  2/877 (0.23%) 
Septic shock  1/886 (0.11%)  0/877 (0.00%) 
Sinusitis  1/886 (0.11%)  1/877 (0.11%) 
Subcutaneous abscess  0/886 (0.00%)  1/877 (0.11%) 
Tonsillitis  2/886 (0.23%)  3/877 (0.34%) 
Tonsillitis bacterial  0/886 (0.00%)  1/877 (0.11%) 
Tooth infection  2/886 (0.23%)  0/877 (0.00%) 
Tracheobronchitis  2/886 (0.23%)  0/877 (0.00%) 
Tuberculosis  1/886 (0.11%)  1/877 (0.11%) 
Tuberculosis gastrointestinal  0/886 (0.00%)  1/877 (0.11%) 
Tuberculous pleurisy  1/886 (0.11%)  0/877 (0.00%) 
Tubo-ovarian abscess  0/886 (0.00%)  1/877 (0.11%) 
Typhoid fever  2/886 (0.23%)  1/877 (0.11%) 
Upper respiratory tract infection  2/886 (0.23%)  3/877 (0.34%) 
Upper respiratory tract infection bacterial  0/886 (0.00%)  1/877 (0.11%) 
Urinary tract infection  5/886 (0.56%)  3/877 (0.34%) 
Viral infection  0/886 (0.00%)  4/877 (0.46%) 
Viral upper respiratory tract infection  1/886 (0.11%)  0/877 (0.00%) 
Vulval abscess  0/886 (0.00%)  1/877 (0.11%) 
Injury, poisoning and procedural complications     
Abdominal injury  1/886 (0.11%)  0/877 (0.00%) 
Alcohol poisoning  0/886 (0.00%)  1/877 (0.11%) 
Ankle fracture  1/886 (0.11%)  0/877 (0.00%) 
Arthropod bite  1/886 (0.11%)  0/877 (0.00%) 
Chemical poisoning  1/886 (0.11%)  0/877 (0.00%) 
Clavicle fracture  0/886 (0.00%)  2/877 (0.23%) 
Concussion  1/886 (0.11%)  1/877 (0.11%) 
Contusion  1/886 (0.11%)  0/877 (0.00%) 
Dislocation of vertebra  0/886 (0.00%)  1/877 (0.11%) 
Exposure to toxic agent  1/886 (0.11%)  0/877 (0.00%) 
Foot fracture  1/886 (0.11%)  0/877 (0.00%) 
Forearm fracture  2/886 (0.23%)  0/877 (0.00%) 
Gun shot wound  1/886 (0.11%)  0/877 (0.00%) 
Hair injury  1/886 (0.11%)  0/877 (0.00%) 
Hand fracture  1/886 (0.11%)  2/877 (0.23%) 
Head injury  0/886 (0.00%)  3/877 (0.34%) 
Humerus fracture  1/886 (0.11%)  0/877 (0.00%) 
Injury  2/886 (0.23%)  0/877 (0.00%) 
Joint dislocation  2/886 (0.23%)  0/877 (0.00%) 
Joint injury  1/886 (0.11%)  0/877 (0.00%) 
Laceration  2/886 (0.23%)  0/877 (0.00%) 
Limb injury  2/886 (0.23%)  2/877 (0.23%) 
Lower limb fracture  1/886 (0.11%)  0/877 (0.00%) 
Overdose  1/886 (0.11%)  0/877 (0.00%) 
Poisoning  1/886 (0.11%)  0/877 (0.00%) 
Post procedural diarrhoea  0/886 (0.00%)  1/877 (0.11%) 
Procedural dizziness  0/886 (0.00%)  1/877 (0.11%) 
Procedural pain  0/886 (0.00%)  1/877 (0.11%) 
Procedural vomiting  0/886 (0.00%)  1/877 (0.11%) 
Radius fracture  1/886 (0.11%)  1/877 (0.11%) 
Rib fracture  1/886 (0.11%)  0/877 (0.00%) 
Skin abrasion  1/886 (0.11%)  1/877 (0.11%) 
Skull fracture  1/886 (0.11%)  0/877 (0.00%) 
Snake bite  0/886 (0.00%)  1/877 (0.11%) 
Soft tissue injury  0/886 (0.00%)  1/877 (0.11%) 
Spinal compression fracture  1/886 (0.11%)  0/877 (0.00%) 
Subdural haematoma  0/886 (0.00%)  1/877 (0.11%) 
Tibia fracture  0/886 (0.00%)  1/877 (0.11%) 
Traumatic haemorrhage  1/886 (0.11%)  0/877 (0.00%) 
Upper limb fracture  3/886 (0.34%)  0/877 (0.00%) 
Investigations     
Alanine aminotransferase increased  20/886 (2.26%)  19/877 (2.17%) 
Aspartate aminotransferase increased  32/886 (3.61%)  29/877 (3.31%) 
Blood albumin decreased  6/886 (0.68%)  9/877 (1.03%) 
Blood alkaline phosphatase increased  0/886 (0.00%)  1/877 (0.11%) 
Blood bicarbonate decreased  1/886 (0.11%)  1/877 (0.11%) 
Blood bilirubin increased  68/886 (7.67%)  42/877 (4.79%) 
Blood cholesterol increased  1/886 (0.11%)  0/877 (0.00%) 
Blood creatinine increased  0/886 (0.00%)  7/877 (0.80%) 
Blood glucose increased  1/886 (0.11%)  1/877 (0.11%) 
Blood phosphorus decreased  73/886 (8.24%)  86/877 (9.81%) 
Blood phosphorus increased  0/886 (0.00%)  2/877 (0.23%) 
Blood potassium decreased  3/886 (0.34%)  1/877 (0.11%) 
Blood potassium increased  2/886 (0.23%)  0/877 (0.00%) 
Blood pressure increased  0/886 (0.00%)  1/877 (0.11%) 
Blood sodium decreased  8/886 (0.90%)  8/877 (0.91%) 
Blood sodium increased  3/886 (0.34%)  2/877 (0.23%) 
Blood triglycerides increased  2/886 (0.23%)  2/877 (0.23%) 
Haemoglobin decreased  15/886 (1.69%)  18/877 (2.05%) 
Hepatic enzyme increased  1/886 (0.11%)  1/877 (0.11%) 
Liver function test abnormal  0/886 (0.00%)  2/877 (0.23%) 
Low density lipoprotein increased  2/886 (0.23%)  2/877 (0.23%) 
Neutrophil count decreased  64/886 (7.22%)  80/877 (9.12%) 
Platelet count decreased  8/886 (0.90%)  19/877 (2.17%) 
Transaminases increased  6/886 (0.68%)  9/877 (1.03%) 
White blood cell count decreased  1/886 (0.11%)  1/877 (0.11%) 
Metabolism and nutrition disorders     
Abnormal loss of weight  75/886 (8.47%)  54/877 (6.16%) 
Decreased appetite  2/886 (0.23%)  5/877 (0.57%) 
Diabetes mellitus  3/886 (0.34%)  5/877 (0.57%) 
Diabetic ketoacidosis  1/886 (0.11%)  1/877 (0.11%) 
Dyslipidaemia  8/886 (0.90%)  6/877 (0.68%) 
Hypercholesterolaemia  2/886 (0.23%)  1/877 (0.11%) 
Hyperglycaemia  4/886 (0.45%)  5/877 (0.57%) 
Hyperkalaemia  2/886 (0.23%)  3/877 (0.34%) 
Hypernatraemia  2/886 (0.23%)  1/877 (0.11%) 
Hyperphosphataemia  0/886 (0.00%)  1/877 (0.11%) 
Hypertriglyceridaemia  4/886 (0.45%)  0/877 (0.00%) 
Hypoalbuminaemia  0/886 (0.00%)  2/877 (0.23%) 
Hypoglycaemia  3/886 (0.34%)  0/877 (0.00%) 
Hypokalaemia  0/886 (0.00%)  1/877 (0.11%) 
Hyponatraemia  2/886 (0.23%)  4/877 (0.46%) 
Hypophosphataemia  42/886 (4.74%)  43/877 (4.90%) 
Lactic acidosis  0/886 (0.00%)  1/877 (0.11%) 
Metabolic acidosis  0/886 (0.00%)  1/877 (0.11%) 
Obesity  1/886 (0.11%)  1/877 (0.11%) 
Type 2 diabetes mellitus  2/886 (0.23%)  5/877 (0.57%) 
Musculoskeletal and connective tissue disorders     
Back pain  3/886 (0.34%)  1/877 (0.11%) 
Flank pain  1/886 (0.11%)  0/877 (0.00%) 
Hypercreatinaemia  0/886 (0.00%)  1/877 (0.11%) 
Intervertebral disc protrusion  0/886 (0.00%)  2/877 (0.23%) 
Myalgia  1/886 (0.11%)  0/877 (0.00%) 
Pain in extremity  0/886 (0.00%)  2/877 (0.23%) 
Plantar fasciitis  0/886 (0.00%)  1/877 (0.11%) 
Spinal osteoarthritis  0/886 (0.00%)  1/877 (0.11%) 
Systemic lupus erythematosus  1/886 (0.11%)  1/877 (0.11%) 
Trigger finger  0/886 (0.00%)  1/877 (0.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma gastric  0/886 (0.00%)  1/877 (0.11%) 
B-cell lymphoma  0/886 (0.00%)  1/877 (0.11%) 
Benign hydatidiform mole  2/886 (0.23%)  0/877 (0.00%) 
Breast cancer  0/886 (0.00%)  1/877 (0.11%) 
Cervix carcinoma  2/886 (0.23%)  0/877 (0.00%) 
Choriocarcinoma  0/886 (0.00%)  1/877 (0.11%) 
Colon adenoma  0/886 (0.00%)  1/877 (0.11%) 
Colorectal adenocarcinoma  1/886 (0.11%)  0/877 (0.00%) 
Hepatocellular carcinoma  1/886 (0.11%)  1/877 (0.11%) 
Hodgkin's disease  1/886 (0.11%)  0/877 (0.00%) 
Non-Hodgkin's lymphoma  1/886 (0.11%)  0/877 (0.00%) 
Phyllodes tumour  1/886 (0.11%)  0/877 (0.00%) 
Rectal adenocarcinoma  0/886 (0.00%)  1/877 (0.11%) 
Uterine leiomyoma  3/886 (0.34%)  2/877 (0.23%) 
Nervous system disorders     
Ataxia  2/886 (0.23%)  0/877 (0.00%) 
Carpal tunnel syndrome  0/886 (0.00%)  1/877 (0.11%) 
Central nervous system lesion  0/886 (0.00%)  1/877 (0.11%) 
Cerebral atrophy  0/886 (0.00%)  1/877 (0.11%) 
Cerebrovascular accident  1/886 (0.11%)  2/877 (0.23%) 
Diplegia  1/886 (0.11%)  0/877 (0.00%) 
Dizziness  14/886 (1.58%)  8/877 (0.91%) 
Dizziness postural  0/886 (0.00%)  1/877 (0.11%) 
Epilepsy  1/886 (0.11%)  1/877 (0.11%) 
Febrile convulsion  1/886 (0.11%)  0/877 (0.00%) 
Haemorrhagic stroke  0/886 (0.00%)  1/877 (0.11%) 
Headache  3/886 (0.34%)  6/877 (0.68%) 
Intracranial venous sinus thrombosis  1/886 (0.11%)  0/877 (0.00%) 
Loss of consciousness  0/886 (0.00%)  1/877 (0.11%) 
Migraine  0/886 (0.00%)  2/877 (0.23%) 
Neuropathy peripheral  0/886 (0.00%)  1/877 (0.11%) 
Paraplegia  0/886 (0.00%)  1/877 (0.11%) 
Polyneuropathy  1/886 (0.11%)  0/877 (0.00%) 
Seizure  1/886 (0.11%)  0/877 (0.00%) 
Somnolence  3/886 (0.34%)  1/877 (0.11%) 
Subarachnoid haemorrhage  0/886 (0.00%)  1/877 (0.11%) 
Syncope  0/886 (0.00%)  1/877 (0.11%) 
Tonic convulsion  0/886 (0.00%)  1/877 (0.11%) 
Transient ischaemic attack  1/886 (0.11%)  0/877 (0.00%) 
Tremor  0/886 (0.00%)  1/877 (0.11%) 
VIIth nerve paralysis  1/886 (0.11%)  0/877 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion  1/886 (0.11%)  0/877 (0.00%) 
Abortion complete  1/886 (0.11%)  1/877 (0.11%) 
Abortion incomplete  6/886 (0.68%)  7/877 (0.80%) 
Abortion missed  2/886 (0.23%)  3/877 (0.34%) 
Abortion spontaneous  9/886 (1.02%)  16/877 (1.82%) 
Abortion spontaneous incomplete  1/886 (0.11%)  1/877 (0.11%) 
Abortion threatened  1/886 (0.11%)  0/877 (0.00%) 
Cephalo-pelvic disproportion  1/886 (0.11%)  0/877 (0.00%) 
Ectopic pregnancy  0/886 (0.00%)  4/877 (0.46%) 
False labour  0/886 (0.00%)  1/877 (0.11%) 
Foetal death  3/886 (0.34%)  2/877 (0.23%) 
Gestational hypertension  0/886 (0.00%)  1/877 (0.11%) 
Haemorrhage in pregnancy  0/886 (0.00%)  1/877 (0.11%) 
Placenta praevia  0/886 (0.00%)  1/877 (0.11%) 
Pre-eclampsia  1/886 (0.11%)  0/877 (0.00%) 
Premature baby  0/886 (0.00%)  1/877 (0.11%) 
Premature labour  0/886 (0.00%)  1/877 (0.11%) 
Premature rupture of membranes  1/886 (0.11%)  1/877 (0.11%) 
Ruptured ectopic pregnancy  0/886 (0.00%)  2/877 (0.23%) 
Stillbirth  4/886 (0.45%)  1/877 (0.11%) 
Psychiatric disorders     
Acute psychosis  1/886 (0.11%)  1/877 (0.11%) 
Acute stress disorder  1/886 (0.11%)  0/877 (0.00%) 
Aggression  1/886 (0.11%)  0/877 (0.00%) 
Anxiety  1/886 (0.11%)  0/877 (0.00%) 
Bipolar disorder  1/886 (0.11%)  0/877 (0.00%) 
Brief psychotic disorder, with postpartum onset  0/886 (0.00%)  1/877 (0.11%) 
Completed suicide  5/886 (0.56%)  3/877 (0.34%) 
Confusional state  1/886 (0.11%)  0/877 (0.00%) 
Depressed mood  1/886 (0.11%)  0/877 (0.00%) 
Depression  4/886 (0.45%)  4/877 (0.46%) 
Drug abuse  0/886 (0.00%)  1/877 (0.11%) 
Hallucination  1/886 (0.11%)  1/877 (0.11%) 
Homicidal ideation  1/886 (0.11%)  0/877 (0.00%) 
Insomnia  2/886 (0.23%)  2/877 (0.23%) 
Intentional self-injury  0/886 (0.00%)  1/877 (0.11%) 
Major depression  4/886 (0.45%)  3/877 (0.34%) 
Mental disorder  1/886 (0.11%)  0/877 (0.00%) 
Psychotic disorder  3/886 (0.34%)  0/877 (0.00%) 
Suicidal ideation  12/886 (1.35%)  5/877 (0.57%) 
Suicide attempt  8/886 (0.90%)  5/877 (0.57%) 
Violence-related symptom  1/886 (0.11%)  0/877 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  2/886 (0.23%)  0/877 (0.00%) 
Calculus ureteric  2/886 (0.23%)  0/877 (0.00%) 
Chronic kidney disease  0/886 (0.00%)  1/877 (0.11%) 
Haematuria  0/886 (0.00%)  3/877 (0.34%) 
Hydronephrosis  1/886 (0.11%)  0/877 (0.00%) 
Nephrolithiasis  2/886 (0.23%)  4/877 (0.46%) 
Nephrotic syndrome  1/886 (0.11%)  0/877 (0.00%) 
Renal colic  2/886 (0.23%)  0/877 (0.00%) 
Renal failure  0/886 (0.00%)  2/877 (0.23%) 
Urogenital fistula  0/886 (0.00%)  1/877 (0.11%) 
Reproductive system and breast disorders     
Cervical dysplasia  3/886 (0.34%)  1/877 (0.11%) 
Dysfunctional uterine bleeding  3/886 (0.34%)  0/877 (0.00%) 
Dysmenorrhoea  1/886 (0.11%)  0/877 (0.00%) 
Erectile dysfunction  1/886 (0.11%)  0/877 (0.00%) 
Gynaecomastia  3/886 (0.34%)  0/877 (0.00%) 
Menorrhagia  4/886 (0.45%)  5/877 (0.57%) 
Menstrual disorder  0/886 (0.00%)  1/877 (0.11%) 
Metrorrhagia  3/886 (0.34%)  2/877 (0.23%) 
Ovarian cyst  2/886 (0.23%)  2/877 (0.23%) 
Pelvic pain  0/886 (0.00%)  1/877 (0.11%) 
Postmenopausal haemorrhage  0/886 (0.00%)  1/877 (0.11%) 
Uterine haemorrhage  2/886 (0.23%)  0/877 (0.00%) 
Vulvovaginal swelling  0/886 (0.00%)  1/877 (0.11%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  2/886 (0.23%)  4/877 (0.46%) 
Dyspnoea  0/886 (0.00%)  1/877 (0.11%) 
Interstitial lung disease  0/886 (0.00%)  1/877 (0.11%) 
Pharyngeal mass  0/886 (0.00%)  1/877 (0.11%) 
Pleurisy  1/886 (0.11%)  0/877 (0.00%) 
Pulmonary embolism  1/886 (0.11%)  1/877 (0.11%) 
Skin and subcutaneous tissue disorders     
Cutaneous lupus erythematosus  0/886 (0.00%)  1/877 (0.11%) 
Decubitus ulcer  1/886 (0.11%)  0/877 (0.00%) 
Lipodystrophy acquired  3/886 (0.34%)  0/877 (0.00%) 
Rash  3/886 (0.34%)  3/877 (0.34%) 
Rash generalised  1/886 (0.11%)  0/877 (0.00%) 
Urticaria  1/886 (0.11%)  1/877 (0.11%) 
Social circumstances     
Victim of homicide  0/886 (0.00%)  1/877 (0.11%) 
Vascular disorders     
Deep vein thrombosis  7/886 (0.79%)  5/877 (0.57%) 
Diabetic vascular disorder  0/886 (0.00%)  1/877 (0.11%) 
Hypertension  8/886 (0.90%)  9/877 (1.03%) 
Systolic hypertension  0/886 (0.00%)  1/877 (0.11%) 
Thromboangiitis obliterans  0/886 (0.00%)  1/877 (0.11%) 
Thrombophlebitis superficial  0/886 (0.00%)  1/877 (0.11%) 
1
Term from vocabulary, MedDRA Body System
[1]
General disorders as well as administration site conditions
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Early-ART Delayed-ART
Affected / at Risk (%) Affected / at Risk (%)
Total   0/886 (0.00%)   0/877 (0.00%) 
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 and five business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Results Point of Contact
Name/Title: Dr. Deborah Donnell
Organization: Fred Hutchinson Cancer Research Center
Phone: 2066675661
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00074581     History of Changes
Other Study ID Numbers: HPTN 052
10068 ( Registry Identifier: DAIDS ES )
First Submitted: December 16, 2003
First Posted: December 17, 2003
Results First Submitted: September 9, 2016
Results First Posted: October 31, 2016
Last Update Posted: November 7, 2016