Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection (PregnantHIV)
Primary Purpose
HIV, Pregnancy
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Raltegravir
Lopinavir/Ritonavir
Sponsored by
About this trial
This is an interventional treatment trial for HIV focused on measuring HIV, Treatment, Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant women with confirmed HIV-1 infection (positive Western blot or plasma HIV-1 RNA >1,000 copies/ml)
- Gestational age higher than 28 weeks
- Age equal or higher than 15 years
- HIV-1 plasma viral load ≥ 1,000 copies of HIV-1 RNA/ml
Exclusion Criteria:
- Age lower than 15 years
- Undetectable plasma viral load at screening
- Previous use of RAL
Sites / Locations
- Fundação Bahiana de Infectologia/SEIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Raltegravir
Lopinavir/Ritonavir
Arm Description
Use of Raltegravir plus backbone treatment for pregnant women
Use of standard PI treatment (Lopinavir/r) plus backbone treatment for pregnant women
Outcomes
Primary Outcome Measures
HIV Viral load at delivery
Secondary Outcome Measures
Overall adverse events at delivery
Number of children infected with HIV
Full Information
NCT ID
NCT01854762
First Posted
April 22, 2013
Last Updated
February 22, 2017
Sponsor
Fundação Bahiana de Infectologia
1. Study Identification
Unique Protocol Identification Number
NCT01854762
Brief Title
Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection
Acronym
PregnantHIV
Official Title
Evaluation of the Use of Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection in Pregnant Women Presenting With Detectable Viral Load After 32 Weeks of Gestation: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundação Bahiana de Infectologia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The current available antiretroviral (ARV) agents make possible a successful treatment of virtually all HIV-infected patients, even those heavily experienced subjects, with a history of previous failure to ARV drugs of different classes. However, some problems are still present, especially for specific populations, like pregnant women and infants. For these groups, most of currently available drugs are not used, because the lack of information on safety, efficacy, and pharmacokinetic/dynamic behavior of ARVs drugs. The mother to child transmission (MTCT) is still a problem in certain areas of the world, especially in resource-limited settings. In some settings, women often present to their first antenatal care visit late in the pregnancy, posing an additional problem: how to effectively treat these patients to assure they will have an undetectable viral load at the moment of delivering? Depending on the plasma viremia magnitude, and viral susceptibility it can take 6 or more weeks to reduce the viral load to less than the desired 1,000 copies of HIV-1 RNA / ml of plasma. To achieve this goal, it would be necessary the use of a potent, very efficacious ARV regimen that could provide such viral decay in a very short period. Raltegravir (RAL), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The available evidence suggest it has no genotoxic potential, and promotes a rapid decline in HIV-1 plasma viremia. In addition, RAL is highly active against viral strains presenting different degree of resistance to other ARV drugs. Thus, RAL could be an ideal candidate to be used for prevention of MTCT for women with detectable viral load, presenting late in the course of pregnancy. Another attractive point is to consider that, due to the similarity between the integrase enzyme of HIV-1 and Human T-cell lymphotropic virus type-1 (HTLV-1); RAL could be active against HTLV-1, blocking its replication. If our hypothesis is correct, the use f RAL-containing ARV regimens would reduce the MTCT of both agents. This study has the objective of evaluating the efficacy of RAL containing ARV regimens in reducing the HIV-1 RNA plasma viral load below 50 copies/ml, at the end of pregnancy, for late-presenters pregnant women and to compare the frequency of adverse events for women using RAL-based ARV regimens and comparators, and for their babies.
Detailed Description
A total of 44 late-presenters (gestational age >28 weeks), HIV-infected pregnant women will be randomly assigned to receive an antiretroviral regimen based on Zidovudine (AZT)+Lamivudine (3TC)+Raltegravir or AZT+3TC+Lopinavir/r (LPV/r). They will be followed up to the delivery, and plasma viral load will be measured. The rate of HIV mother-to-child-transmission will be compared between groups. The newborns will be followed up to 6 months, to register any adverse event during this period of time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Pregnancy
Keywords
HIV, Treatment, Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Raltegravir
Arm Type
Experimental
Arm Description
Use of Raltegravir plus backbone treatment for pregnant women
Arm Title
Lopinavir/Ritonavir
Arm Type
Active Comparator
Arm Description
Use of standard PI treatment (Lopinavir/r) plus backbone treatment for pregnant women
Intervention Type
Drug
Intervention Name(s)
Raltegravir
Intervention Description
a raltegravir-based antiretroviral regimen (AZT+3TC+Raltegravir) will be administered for intervention arm patients (AZT+3TC will be administered in a fixed combination of AZT 300mg +3TC 150 mg, BID. Raltegravir will be administered in a dosis of 1 400 mg pill BID).
Intervention Type
Drug
Intervention Name(s)
Lopinavir/Ritonavir
Intervention Description
The second arm (comparator)patients will use a regimen composed by AZT+3TC (same dosis/schedule of active arm)+ LPV 200mg combined with rtv 50 mg, 2 pills BID
Primary Outcome Measure Information:
Title
HIV Viral load at delivery
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Overall adverse events at delivery
Time Frame
2 months
Title
Number of children infected with HIV
Time Frame
24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women with confirmed HIV-1 infection (positive Western blot or plasma HIV-1 RNA >1,000 copies/ml)
Gestational age higher than 28 weeks
Age equal or higher than 15 years
HIV-1 plasma viral load ≥ 1,000 copies of HIV-1 RNA/ml
Exclusion Criteria:
Age lower than 15 years
Undetectable plasma viral load at screening
Previous use of RAL
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Estela Luz, RN, MSci
Phone
32838123
Email
eluz5@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Brites, MD, PhD
Organizational Affiliation
Fundação Bahiana de Infectologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundação Bahiana de Infectologia/SEI
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40110-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estela Luz, RN, MSci
Phone
32838123
Email
eluz5@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Ana Gabriela A Travassos, MD, MSci
First Name & Middle Initial & Last Name & Degree
Isabela Nobrega, MD, MSci
12. IPD Sharing Statement
Learn more about this trial
Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection
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