| CTRI Number |
CTRI/2009/091/000644 [Registered on: 09/12/2009] |
| Last Modified On: |
24/08/2015 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
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A Study in couples in which one partner is infected with HIV and the other partner is not infected. The primary goal is to find out whether treating HIV infected partner with Anti-HIV drugs can prevent them from transmitting the virus to their partner through sex |
Scientific Title of Study
Modification(s)
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A randomized trial to evaluate the effectiveness of antiretroviral therapy plus HIV primary care versus HIV primary care alone to prevent the sexual transmission of HIV-1 in Serodiscordant couples |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| HPTN O52, Version 3.0,dated 20 Nov 2006 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
DrSanjay Mehendale |
| Designation |
Principal investigator |
| Affiliation |
National AIDS Research Institute |
| Address |
National AIDS Research Institute 73, G Block MIDC,Bhosari,
Pune
MAHARASHTRA
411 026
India |
| Phone |
91-20-27331200 |
| Fax |
91-20-27121071 |
| Email |
smehendale@nariindia.org |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DrSheela Godbole |
| Designation |
Investigator of Record |
| Affiliation |
National AIDS Research Institute |
| Address |
73, G Block MIDC,Bhosari
Pune
MAHARASHTRA
411 026
India |
| Phone |
91-20-27331200 |
| Fax |
91-20-27121071 |
| Email |
sgodbole@nariindia.org |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
DrSheela Godbole |
| Designation |
Investigator of Record |
| Affiliation |
National AIDS Research Institute |
| Address |
73, G Block MIDC,Bhosari
Pune
MAHARASHTRA
411 026
India |
| Phone |
91-20-27331200 |
| Fax |
91-20-27121071 |
| Email |
sgodbole@nariindia.org |
|
Source of Monetary or Material Support
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| Division of Acquired Immunodeficiency Syndrome (DAIDS)
National Institute of Health USA |
|
Primary Sponsor
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| Name |
National Institute of Health USA |
| Address |
Department of Health and Human services ,NIH,U.S. |
| Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
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|
|
Countries of Recruitment
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India
Botswana
Brazil
Malawi
South Africa
Thailand
Zimbabwe |
Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sheela Godbole |
National AIDS Research Institute |
73 G, Block, MIDC, Bhosari, Pune
Pune
MAHARASHTRA |
020-27331200
91-20-27121071
sgodbole@nariindia.org |
|
Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NARI Ethics Committtee |
Approved |
|
Regulatory Clearance Status from DCGI
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|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Find out whether treating HIV infected people with anti HIV drugs will prevent them from transmitting the virus to their partner through sex.
, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Delayed ART arm |
Stdy participant will receive only HIV primary care without initiation of ART until the index participant has two consecutive measurements of a CD4+ cell count within or below the range of 200-250 cells/mm3, or develops an
AIDS-defining illness.
|
| Intervention |
immediate ART arm |
The study partcipant on this arm will receive immediate ART therapy plus HIV primary care |
|
Inclusion Criteria
Modification(s)
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| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Couples are defined as sexual partners same or opposite sex who are married have been
living together or consider each other a primary partner. They must have been together for a minimum of three months and at the time of study enrollment expect to maintain their relationship for the duration of the study.
Index Case:
-Positive HIV serology obtained within 60 days prior to enrollment
-Has a sexual partner (as defined above) who is not infected with HIV (documented by negative HIV serology) and who is willing to participate in the study.
-Plans to maintain a sexual relationship with the person who is enrolled in the study with them.
-Reports having sex (vaginal or anal) with partner at least 3 times in the last 3 months.
-If pregnant or breastfeeding during screening or at the time of enrollment, willing to be randomized to either arm of the study.
-The following conditions must be met for laboratory parameters within 60 days prior to enrollment:
CD4+ cell count of 350-550 cells/mm3
Hemoglobin > 7.5 g/dL
Platelet count > 50,000/µL.
AST (SGOT), ALT (SGPT), and alkaline phosphatase < 5 x ULN
Total bilirubin < 2.5 x ULN
Calculated creatinine clearance > 60 mL/min (use the Cockcroft and Gault method to calculate)
Absolute neutrophil count > 750 mm3 or 0.750 x 109/L
Partner
-Negative HIV serology within 14 days prior to enrollment.
-Has a sexual partner infected with HIV who is willing to participate in the study.
-Plans to maintain a sexual relationship with the person who is enrolled in the study with them.
-Reports having sex (vaginal or anal) with partner at least 3 times in the last 3 months.
Both Index Case and Partner:
-Men and women age > 18 years.
-Willing to disclose HIV test results to partner.
-Not intending to relocate out of the area for the duration of study participation and does not have a job or other obligations that may require long absences from the area. |
|
| ExclusionCriteria |
| Details |
Index Case:
-Current or previous AIDS-defining illness (as defined in Appendix III).
-Current or previous use of any ART drugs
-Documented or suspected acute hepatitis within 30 days prior to enrollment, irrespective of AST (SGOT) and ALT (SGPT) values.
-Acute therapy for serious medical illnesses, chronic, acute, or recurrent infections in the opinion of the site investigator
-Radiation therapy or systemic chemotherapy, any immunomodulator or other investigational therapy, Active drug or alcohol use or dependence, Allergy/sensitivity to any study drugs.
Both Index Case and Partner:
-Reports a history of injection drug use within the last five years.
-Previous and/or current participant in an HIV vaccine study.
-Any condition that, in the opinion of the study staff, would make participation in the study unsafe
-Incarceration in a correctional facility |
|
Method of Generating Random Sequence
Modification(s)
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Permuted block randomization, fixed |
Method of Concealment
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Not Applicable |
Blinding/Masking
Modification(s)
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Open Label |
Primary Outcome
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| Outcome |
TimePoints |
| HIV infection in partners |
Throughout study |
|
Secondary Outcome
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|
| Outcome |
TimePoints |
| Determine, characterize, and compare the rates of AIDS-defining illnesses, sexually transmitted diseases, opportunistic infections, and immune reconstitution syndromes, with regard to outcomes and survival as observed in different geographic settings and by antiretroviral treatment strategies. |
Throughout study |
|
Target Sample Size
Modification(s)
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Total Sample Size="1750"
Sample Size from India="175"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
01/07/2005 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
21/02/2005 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
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1. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011;365(6):493-505.
2. Eshleman SH, Hudelson SE, Redd AD, Wang L, Debes R, Chen YQ, et al. Analysis of Genetic Linkage of HIV From Couples Enrolled in the HIV Prevention Trials Network 052 Trial. J Infect Dis. 2011;204(12):1918-26.
3. Cohen, MS, McCauley, M, Gamble T. HIV treatment as prevention and HPTN 052. Current Opinion in HIV & AIDS. 1 March 2012; 7(2):97-209.
4. Cohen, MS, McCauley, M, Sugarman, J. Establishing HIV treatment as prevention in the HIV Prevention Trials Network 052 randomized trial: an ethical odyssey. Clin Trials. 2012;9(3):340-7. |
|
Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
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HPTN 052 is a Phase III, two-arm, randomized, controlled, multi-center trial. The purpose of this study is to determine whether antiretroviral therapy (ART) can prevent the sexual transmission of HIV-1 in HIV-1 serodiscordant couples. This trial consists of a run-in period, which has been completed, and a full study. The target sample size for the full study is approximately 1,750 couples including 82 couples (globally) that enrolled in the run-in period. The enrollment target at NARI site is 200 and at YRG care is 250. The duration of the full study will be approximately 78 months total. Accrual into the study will require approximately 18 months, and all couples will be followed until the last couple enrolled completes their 60-month follow-up visit. The enrollment at NARI sites started in 01 July 2005 and YRG care started in 10 November 2005. Total Enrollments globally as of August 14, 2009 are 1242. Serodiscordant couples in which the HIV-infected index participant is ART-naïve and has a CD4+ cell count of 350-550 cells/mm3 are randomized to receive either immediate ART therapy plus HIV primary care or HIV primary care without initiation of ART until the index participant has two consecutive measurements of a CD4+ cell count within or below the range of 200-250 cells/mm3, or develops an AIDS-defining illness. The primary objective of this study is to compare rates of HIV infection among partners of HIV-infected index participants in the two arms. |