NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Female

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) for the prevention of mother-to-child transmission (MTCT) of HIV may not respond as well to NNRTIs as women who have never taken NVP. Another class of anti-HIV drugs, protease inhibitors (PIs), may be more effective for women who have previously taken NNRTIs. This study will compare the effectiveness of NNRTI- and PI-based regimens in women who have taken NVP for prevention of MTCT of HIV. This study will also compare regimens including an NNRTI with regimens including a PI in women who have never taken NVP.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIDS Clinical Trials Group
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lopinavir; Nevirapine; Ritonavir; Tenofovir

Criteria

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