- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01854762
Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection (PregnantHIV)
February 22, 2017 updated by: Carlos Brites, Fundação Bahiana de Infectologia
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
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Estela Luz, RN, MSci
- Phone Number: 32838123
- Email: eluz5@yahoo.com.br
Study Locations
-
-
Bahia
-
Salvador, Bahia, Brazil, 40110-010
- Recruiting
- Fundação Bahiana de Infectologia/SEI
-
Contact:
- Estela Luz, RN, MSci
- Phone Number: 32838123
- Email: eluz5@yahoo.com.br
-
Sub-Investigator:
- Ana Gabriela A Travassos, MD, MSci
-
Sub-Investigator:
- Isabela Nobrega, MD, MSci
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Raltegravir
Use of Raltegravir plus backbone treatment for pregnant women
|
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).
|
Active Comparator: Lopinavir/Ritonavir
Use of standard PI treatment (Lopinavir/r) plus backbone treatment for pregnant women
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HIV Viral load at delivery
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall adverse events at delivery
Time Frame: 2 months
|
2 months
|
Number of children infected with HIV
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carlos Brites, MD, PhD, Fundação Bahiana de Infectologia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
June 1, 2017
Study Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
April 22, 2013
First Submitted That Met QC Criteria
May 13, 2013
First Posted (Estimate)
May 16, 2013
Study Record Updates
Last Update Posted (Actual)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 22, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Integrase Inhibitors
- Integrase Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Raltegravir Potassium
- Ritonavir
- Lopinavir
Other Study ID Numbers
- PregnantHIV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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