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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Adult AIDS Clinical Trials Group |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00089505 |
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are commonly included in anti-HIV drug regimens. However, HIV infected women who have previously taken the NNRTI nevirapine (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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Emtricitabine Drug: Emtricitabine/Tenofovir disoproxil fumarate Drug: Lopinavir/Ritonavir Drug: Nevirapine Drug: Tenofovir disoproxil fumarate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Optimal Combination Therapy After Nevirapine Exposure |
Estimated Enrollment: | 740 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
FTC, TDF, and NVP daily the first 14 days, then twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV twice daily plus two more NRTIs.
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Drug: Emtricitabine
200 mg taken orally
Drug: Emtricitabine/Tenofovir disoproxil fumarate
200/300 mg taken orally
Drug: Lopinavir/Ritonavir
400/100 mg taken orally
Drug: Nevirapine
200 mg taken orally
Drug: Tenofovir disoproxil fumarate
300 mg taken orally
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B: Experimental
FTC and TDF daily and LPV/RTV twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily for 14 days before taking it twice daily. plus 2 more NRTIs.
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Drug: Emtricitabine
200 mg taken orally
Drug: Emtricitabine/Tenofovir disoproxil fumarate
200/300 mg taken orally
Drug: Lopinavir/Ritonavir
400/100 mg taken orally
Drug: Tenofovir disoproxil fumarate
300 mg taken orally
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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 regimens containing NVP. PIs are more expensive and cause different adverse effects than NNRTIs, but PI-containing regimens may be more effective than NNRTI-containing regimens in treating HIV infected women who previously took NVP for MTCT prophylaxis. This study will compare the efficacy of NNRTI- and PI-containing anti-HIV regimens in women who have previously taken NVP for MTCT of HIV and in women who have never taken NVP.
The study will last a minimum of 48 weeks. Participants will be grouped by previous NVP exposure: participants who have previously taken NVP as MTCT prophylaxis (Trial 1 participants), and participants who have never taken NVP (Trial 2 participants). Participants in each trial will be randomly assigned to one of two arms, A or B. At the start of the study, Arm A participants will receive emtricitabine (FTC) daily, tenofovir disoproxil fumarate (TDF) daily, and NVP daily for the first 14 days, then twice daily. Arm B participants will receive both FTC and TDF daily and lopinavir/ritonavir (LPV/RTV) twice daily. FTC and TDF may be replaced in either arm with the combination drug FTC/TDF.
If participants experience virologic failure, toxicity, or otherwise cannot tolerate their regimens, they will switch to a different regimen. Arm A participants will switch to a regimen of two or more nucleoside reverse transcriptase inhibitors (NRTIs) and LPV/RTV; Arm B participants will switch to a regimen of two or more NRTIs and NVP. Study visits will occur at entry and at Weeks 2, 4, 8, 12, 16, 24, 36, and 48. Visits will consist of a physical exam, medication assessment, and blood collection. Participants will be asked to complete adherence questionnaires at Weeks 4, 12, 24, and 28 and quality of life questionnaires at Weeks 24 and 48.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for All Participants:
Inclusion Criteria for Trial 1 Participants:
Exclusion Criteria for All Participants:
Botswana | |
Molepolole BHP Study Clinic, Scottish Livingstone Hospital | |
Bontleng Gaborone, Botswana | |
Botswana, Gaborone | |
The Gaborone BHP Study Clinic | |
Bontleng, Gaborone, Botswana | |
Kenya | |
KMRI / Walter Reed Project Clinical Research Center | |
Kericho, Kenya | |
Moi University International Clnical Trials Unit | |
Eldoret, Kenya, 30100 | |
Malawi | |
University of North Carolina Project (UNC Project) | |
Lilongwe, Malawi, (265) 175-5056 | |
Kamuzu Central Hospital, Tidziwe Centre | |
Lilongwe, Malawi | |
South Africa | |
University of Witwatersrand | |
Johannesburg, South Africa | |
Chris Hani Baragwanath Hospital, Johannesburg | |
Johannesburg, South Africa | |
South Africa, KZN | |
University of KwaZulu Natal | |
Durban, KZN, South Africa, 4013 | |
Uganda | |
Joint Clinical Research Centre (JCRC) | |
Kampala, Uganda | |
Zambia | |
Centre for Infectious Disease Research in Zambia (CIDRZ) | |
Lusaka, Zambia | |
Zimbabwe, Harare | |
University of Zimbabwe | |
Avondale, Harare, Zimbabwe |
Study Chair: | Shahin Lockman, MD, MSc | Brigham and Women's Hospital and Infectious Diseases Division, Department of Immunology and Infectious Diseases, Harvard School of Public Health |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | ACTG A5208, OCTANE |
Study First Received: | August 5, 2004 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00089505 |
Health Authority: | United States: Federal Government |
Treatment Experienced Treatment Naive MTCT HIV Seronegativity |
Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases Nevirapine Emtricitabine Lopinavir |
HIV Infections Ritonavir Sexually Transmitted Diseases Tenofovir Retroviridae Infections Tenofovir disoproxil |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |