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Trial record 1 of 1 for:    HPTN 052
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Preventing Sexual Transmission of HIV With Anti-HIV Drugs

This study has been completed.
Sponsor:
Collaborator:
HIV Prevention Trials Network
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00074581
First received: December 16, 2003
Last updated: November 3, 2016
Last verified: November 2016
Results First Received: September 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Early-ART

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.

Delayed-ART

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.


Participant Flow:   Overall Study
    Early-ART   Delayed-ART
STARTED   1789 [1]   1767 [2] 
COMPLETED   1545   1541 
NOT COMPLETED   244   226 
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Early-ART

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.

Delayed-ART

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 Total of all reporting groups

Baseline Measures
   Early-ART   Delayed-ART   Total 
Overall Participants Analyzed 
[Units: Participants]
 1789   1767   3556 
Age, Customized 
[Units: Participants]
     
18-25 yr   300   335   635 
26-40 yr   1101   1079   2180 
>40 yr   388   353   741 
Gender 
[Units: Participants]
Count of Participants
     
Female      877  49.0%      860  48.7%      1737  48.8% 
Male      912  51.0%      907  51.3%      1819  51.2% 
Region 
[Units: Participants]
     
North or South America   293   279   572 
Asia   535   528   1063 
Africa   961   960   1921 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms   [ Time Frame: Throughout study ]

2.  Primary:   All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms   [ Time Frame: Throughout study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Deborah Donnell
Organization: Fred Hutchinson Cancer Research Center
phone: 2066675661
e-mail: deborah@scharp.org


Publications:
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 )
Study First Received: December 16, 2003
Results First Received: September 9, 2016
Last Updated: November 3, 2016
Health Authority: United States: Food and Drug Administration