Status:
COMPLETED
HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV
Lead Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
FEMALE
16+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if pregnancy-limited, short-term combination HIV treatment regimens -- which were used solely for the prevention of mother to child transmission of HIV and di...
Detailed Description
Stopping and restarting highly active antiretroviral therapy (HAART) is not generally recommended because it has the potential to allow drug-resistant HIV to emerge. However, to prevent mother-to-chil...
Eligibility Criteria
Inclusion
- HIV-1 infected
- Viral load of 500 copies/mL or more
- Prior HAART for more than 7 days, but less than 40 weeks during at least one previous pregnancy for prevention of MTCT of HIV
- Clinical or laboratory indication to start HAART, in the opinion of the participant's physician
- Certain laboratory values
- Willingness to use acceptable forms of contraception
- Parent or guardian willing to provide informed consent, if applicable
Exclusion
- Taking any antiretroviral medication within 24 weeks prior to study entry
- Evidence of certain HIV-1 RT mutations within 90 days prior to study entry (version 1.0)
- Evidence of certain HIV-1 RT mutations identified by standard bulk viral population genotypic resistance tests at any time prior to study entry, if available (version 2.0, 09/03/2009)
- Treatment at any time, for any reason with nevirapine as a single agent OR addition of any part of the study regimen as a single agent to a failing regimen
- Use of certain antihistamines, certain anti-infectives, cisapride, St John's wort, midazolam, triazolam, dihydroergotamine, ergonovine, ergotamine, or methylergonovine within 14 days prior to study entry
- Use of HIV vaccine, chronic systemic corticosteroids, interleukins, interferons, other cytokines, or investigational therapy within 30 days prior to study entry
- Acute or chronic therapy for certain serious medical illnesses within 14 days of study entry. Participants who have completed 7 days of therapy and are judged clinically stable are not excluded.
- Cancer requiring systemic chemotherapy
- Known allergy/sensitivity to the study drugs or their formulations
- Current drug or alcohol use that, in the opinion of the investigator, would interfere with the study
- Two consecutive HIV viral loads of more than 5,000 copies/mL 8 weeks or more following initiation of HAART during pregnancy and while still receiving HAART
- Two consecutive viral loads of more than 400 copies/mL 24 weeks or more following initiation of HAART during pregnancy while still receiving HAART
- Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical illness
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00442962
Start Date
May 1 2007
End Date
December 1 2010
Last Update
October 12 2018
Active Locations (9)
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1
Ucsd, Avrc
San Diego, California, United States, 92103
2
Brigham and Women's Hospital, Division of Infectious Disease
Boston, Massachusetts, United States, 02115
3
Washington University School of Medicine
St Louis, Missouri, United States, 63108
4
Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea
New York, New York, United States, 10011