Status:
COMPLETED
NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission
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
13+ years
Phase:
PHASE3
Brief Summary
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are commonly included in anti-HIV drug regimens. However, HIV infected women who have previously taken the single dose NNRTI nevirapine (SD NVP...
Detailed Description
NVP is the NNRTI of choice to prevent MTCT of HIV, especially in resource-limited settings. However, prolonged use of NVP may result in drug resistance, decreasing the efficacy of future anti-HIV regi...
Eligibility Criteria
Inclusion
- Inclusion Criteria for All Participants:
- HIV infected
- CD4 count less than 200 cells/mm\^3 within 90 days prior to study entry
- Plasma HIV-1 RNA using standard Roche Amplicor HIV-1 Monitor Assay within 45 days prior to study entry
- the following laboratory values obtained within 45 days prior to study entry: absolute neutrophil count\>=750/mm\^3;Hemoglobin\>=7.0g/dL;platelet count\>=50000/mm\^3;aspartate aminotransferase (AST),Alanine aminotransferase (ALT), and alkaline phosphatase \<=2.5 x ULN; total bilirubin \<=2.5 x ULN
- Normal renal function within 45 days prior to study entry
- Willing to use acceptable forms of contraception
- Karnofsky performance score \>=70 on at least one occasion within 45 days prior to study entry
- Parent or guardian willing to provide informed consent, if applicable
- Planning to remain in the same geographical area of residence and are willing to attend study visits as required
- Inclusion Criteria for Trial 1 Participants:
- Previously received NVP for prevention of MTCT of HIV
- Has documentation of all prior doses of NVP used for prevention of MTCT of HIV
- Last dose of NVP for prevention of MTCT of HIV taken at least 6 months prior to study entry
- Exclusion Criteria for All Participants:
- Previously received any antiretrovirals, excluding NVP for MTCT prophylaxis for Trial 1 participants. Participants who have received up to 10 weeks of zidovudine alone and completed this course at least 6 months prior to study entry are not excluded.
- Use of systemic cancer chemotherapy, systemic investigational agents, immunomodulators, or rifampin within 30 days of study entry
- Pregnant or breastfeeding
- Known allergy or sensitivity to study drugs or their formulations
- Any condition, including drug or alcohol abuse, that, in the opinion of the investigator, may interfere with adherence to study regimens
- Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 30 days prior to study entry are not excluded.
- Tuberculosis (TB) treatment within 30 days prior to study entry
- Use of any prohibited medications within 30 days prior to study entry
- Involuntary incarceration in a correctional facility, prison, or jail for legal reasons or in a medical facility for treatment of either a psychiatric or physical illness
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
745 Patients enrolled
Trial Details
Trial ID
NCT00089505
Start Date
November 1 2006
End Date
February 1 2011
Last Update
October 12 2018
Active Locations (11)
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1
The Gaborone BHP Study Clinic
Bontleng, Gaborone, Botswana
2
Molepolole BHP Study Clinic, Scottish Livingstone Hospital
Bontleng Gaborone, Botswana
3
Moi University International Clnical Trials Unit
Eldoret, Kenya, 30100
4
KMRI / Walter Reed Project Clinical Research Center
Kericho, Kenya