None listed
Conditions
Interventions
This group will be treated with Ataznavir, 2 capsules of 150 mg QID PO, Ritonavir 1 capsule of 100 mg QID PO, Tenofovir / Emtricitabine 1 tablet of 300/200 mg QID PO
GROUP II Type of group
This group will be treated with Lopinavir / Ritonavir, 3 capsules of 133 / 33.3 mg BID PO, Tenofovir / Emtricitabine 1 tablet of 300/200 mg QID PO
This scheme will be administered every day for 96 weeks.
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Provide informed consent in writing, assess whether the patient is able to read and understand the content of informed consent. 2) Qualifying plasma level of HIV RNA> 5,000 c / ml. 3) Men and women over 18 years of age. 4) Women of childbearing age (FEM) should use a method of birth control that is appropriate. 5) Women of childbearing age must present a negative result in the pregnancy test performed in serum or urine.
Exclusion criteria
Exclusion criteria: 1) WFAs that are not willing or able to use a method of birth control that is acceptable. 2) The WFAs that are using a prohibited contraceptive method. 3) Pregnant or lactating women. 4) Women who have obtained a positive result in the pregnancy test. 5) Presence of newly diagnosed HIV-related opportunistic infection, or any clinical condition that requires acute therapy at the time of enrollment. 6) Suspected primary infection (acute) due to HIV. 7) Any antiretroviral therapy in the 30 days prior to selection. 8) Previous antiretroviral therapy for> 1 week. 9) Subjects with Cushing´s syndrome. 10) Untreated hypothyroidism or hyperthyroidism. 11) Recent therapy with drugs that have a significant myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential in the previous 3 months. 12) Subjects with obstructive liver disease. 13) Active abuse of alcohol or substances that is sufficient to prevent adequate compliance with the therapy under study, or may increase the risk of developing pancreatitis or drug hepatitis. 14) Acute hepatitis proven or suspected within 30 days prior to admission to the study. 15) Intractable diarrhea during the 30 days prior to admission to the study. 16) Impossibility of swallowing the capsules. 17) Active peripheral neuropathy. 18) Presence of cardiomyopathy or of any significant cardiovascular disease. 19) Clinically significant known disease of the cardiac conduction system. 20) Moderate to severe hepatic insufficiency. 21) Laboratory values ​​not acceptable in the selection. 22) Hypersensitivity to any of the ingredients of the study medication formula. 23) Receive any of the prohibited therapies. 24) Any other clinical condition or previous therapy that would make the patient unfit to continue in the study, or unable to meet the requirements of the treatment. 25) Prisoners or subjects who are compulsorily arrested may not be enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Roche Ampllcor® PCR version 1.5 for HIV RNA in peripheral blood samples. Measure:Proportion of patients with HIV RNA <50 c / ml in Week 48. Timepoints:Before starting the study, day 1, weeks 4, 12, 24, 36, 48, 60, 72, 84, 96 or in a possible early termination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Roche Ampllcor® PCR version 1.5 for HIV RNA in peripheral blood samples. CD4 cell count. Measure:Proportion of patients with HIV RNA <400 c / ml at Week 48. Proportion of patients with HIV RNA <50 c / ml and HIV <400 c / ml at week 96. Time to loss of virological response. Reduction of HIV RNA log10 from the baseline to Weeks 48 and 96. CD4 cell count from baseline to Weeks 48 and 96. Timepoints:Before starting the study, day 1, weeks 4, 12, 24, 36, 48, 60, 72, 84, 96 or in a possible early termination. ; Outcome name:Evaluation of adverse events. Lipidic profile. Insulin fasting. Hematology profile, serum chemistry Serology of hepatitis. Measure:Safety and tolerability of the regimes. Changes in laboratory tests. Timepoints:Evaluation of adverse events and laboratory tests: Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96 or in a possible early termination. Serology of hepatitis: Before starting the study, weeks 48 and 96 or in a possible early termination. ; Outcome name:Aliquots of 2 ml of frozen plasma to analyze the viral resistance of the phenotype and 2 aliquots of 2 ml of frozen plasma to analyze the viral resistance of the genotype. Measure:Antiretroviral resistance. Timepoints:Day 1, weeks 4, 12, 24, 36, 48, 60, 72, 84, 96 or in a possible early termination. ; Outcome name:Survey of Medical Results-Human Immunodeficiency Virus (MOS-HIV). Questionnaire for Irritable Bowel Syndrome-Quality of Life (IBS-QOL). Measure:Quality of life. Timepoints:MOS-HIV: Weeks 12, 24, 48, 96 or in a possible early termination. IBS-QOL: Weeks 4, 12, 24, 48. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Indonesia, Italy, Mexico, Netherlands, Panama, Portugal, Singapore, South Africa, Spain, Taiwan, Thailand, United Kindgdom, United States
Outcome results
None listed