Health Condition 1: null- HIV Infections
Conditions
Interventions
Intervention1: Drug: Atazanavir,Drug: Didanosine (enteric-coated), Drug: Efavirenz,Drug: Emtricitabine,Drug: Emtricitabine/Tenofovir disoproxil fumarate,Drug: Lamivudine/Zidovudine: HIV Infections Pha
Sponsors
National Institute of Allergy And Infection Diseases NIAIDUSA
Adult AIDS Clinical Trial Group
Eligibility
Inclusion criteria
Inclusion criteria: HIV-1 infected Prior ARV therapy for 7 days or less at any time prior to study entry CD4 count less than 300 cells/mm3 within 90 days prior to study entry Viral load test within 45 days prior to study entry Plans to stay in the area for the duration of the study Willing to adhere to study follow-up schedule Agrees to use acceptable forms of contraception for the duration of the study Virologic failure, defined as two successive viral load tests of 1000 copies/ml or greater OR either progression to AIDS after at least 12 weeks following study entry OR a decrease in CD4 count to less than 50% of the Step 1 maximum in absence of confirmed virologic failure after at least 12 weeks following study entry. More information on this criterion can be found in the protocol. Received counseling on treatment adherence Willing to switch to a new ARV treatment regimen Site investigator recommends a new ARV regimen for the management of presumed or documented drug resistance Received administrative approval to enter Step 2
Exclusion criteria
Exclusion criteria: Acute therapy for serious medical illnesses within 14 days prior to study entry. Patients with serious infection who must continue with chronic maintenance therapy must be clinically stable and have completed at least 14 days of therapy prior to study entry. Certain abnormal laboratory values Radiation therapy or chemotherapy within 45 days prior to study entry. Patients on systemic chemotherapy for treatment of Kaposi's sarcoma within 45 days of study entry are not excluded, provided the chemotherapy is completed prior to study entry. Any immunomodulator, HIV vaccine, or other investigational therapy within 30 days prior to study entry. Patients taking tapered courses of corticosteroids for acute therapy for Pneumocystis carinii pneumonia (PCP) are not excluded. Current alcohol or drug abuse that, in the opinion of the site investigator, would interfere with study participation Inflamed pancreas within 3 years prior to study entry Currently enrolled in ACTG A5001 or A5164 Allergy/sensitivity to any of the study drugs or their formulations Heart rate less than 40 beats/min History of untreated, active second- or third-degree heart block Require certain medications Currently detained in jail or for treatment of a psychiatric or physical illness Vomiting or inability to swallow medications Any condition that, in the opinion of the site investigator, would compromise study participation Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to treatment failure, defined as the time from study entry to the first occurrence of virologic failure, disease progression, or death [ Time Frame: At least 12 weeks following study entry. Virologic failure will be measured at the Week 16 visit or later. ] [ Designated as safety issue: No ] Timepoint: at least 12 weeks following randomization. at the week 16 visit or later. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Time to discontinuation of intitial antiretroviral therapy 2.Time to immunologic failure Change in CD4 count 3.modification or Grade 3 or 4 toxicity 4.Viral load less than 400 copies/ml Time to loss of virologic response [ Time Frame: Throughout the study ] [ Designated as safety issue: No ] Timepoint: 1. Time Frame: Throughout the study 2.at weeks 24 and 48 3.Throughout the study 4.At Weeks 24 and 48 | — |
Countries
India, Thailand
Contacts
Public ContactDr Srikanth Tripathy
ICMR
Outcome results
None listed