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ALTAIR - Alternative Antiretroviral Strategies : a Comparison of Three Initial Regimens

2014-08-27 03:44:14 | BioPortfolio

Summary

In treatment naïve HIV infected subjects, combination antiretroviral therapy including efavirenz combined with tenofovir and emtricitabine will offer non-inferior antiretroviral efficacy over 48 weeks, compared to either atazanavir boosted with ritonavir combined with tenofovir and emtricitabine or tenofovir and emtricitabine combined with zidovudine and abacavir, as assessed by change from baseline plasma HIV-1 RNA viral load.

Description

The primary objective of this study is to compare the virological efficacy, as measured by the time-weighted mean change from baseline plasma HIV-RNA, and safety, of three strategic regimens of initial antiretroviral therapy (ART) containing a fixed dose formulation of tenofovir and emtricitabine, with either efavirenz or ritonavir boosted atazanavir or zidovudine plus abacavir. (Primary comparisons are regimen I versus II and I versus III as described below).

I. tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV) II. tenofovir (TDF) + emtricitabine (FTC) + ritonavir/atazanavir (r/ATV) III. tenofovir (TDF) + emtricitabine (FTC) + zidovudine (ZDV) + abacavir (ABC)

Secondary objectives of this study will be to undertake a range of analyses including but not limited to the following,

1. Percentage of patients < 50 copies HIV RNA/mL (and < 400 copies/mL) at week 48 and week 96 between treatment arms.

2. Time to confirmed (first of two consecutive) plasma HIV-1 RNA < 50 copies/mL (and < 400 copies/mL) between treatment arms.

3. Time to virologic failure defined as confirmed plasma HIV-1 RNA > 50 copies/mL (and 400 copies/mL) after confirmed < 50 copies/mL (where time = 0 if patient never achieves plasma virus load < 50 or <400 copies/mL).

4. Mean change from baseline of absolute CD4+ T cell count at weeks 48 and 96 between treatment arms.

5. Time to change in randomly assigned therapy (all reasons individually and on aggregate) between treatment arms.

6. Time to first virologic failure (defined as #3 above) or cessation of randomly assigned antiretroviral therapy.

7. Mean change from baseline Lipodystrophy Case Definition score at weeks 48 and 96 between treatment arms.

8. Mean change from baseline in peripheral and central adipose tissue, as measured by CT and DEXA at weeks 48 and 96 between treatment arms.

9. Mean change from baseline in fasting lipid and glycemic parameters at weeks 48 and 96 between treatment arms.

10. Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs, between treatment arms.

11. Comparison of total number of patients with any adverse events (AEs), and the cumulative incidence of AEs, associated with cessation of randomly assigned therapy between treatment arms.

12. Patterns of genotypic HIV resistance associated with virological treatment failure across treatment arms.

13. Describe aspects of immune reconstitution disease.

14. Adherence to therapy and associations with virologic outcomes between treatment arms.

15. Comparison of quality of life between treatment arms.

Following the result of the scheduled week 48 data analysis, the protocol steering committee amended the study protocol as follows:

- Patients on Arms I and II will remain on the current study drugs

- Patients on Arm III may be switched at the physician's discretion to either Arm I or II

- There will be a protocol amendment to include one extra follow up visit at week 144 for all patients, regardless of treatment arm or current treatment

- All patients are to be encouraged to stay on the study up to week 144, to maximize follow up on study.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Human Immunodeficiency Virus (HIV)

Intervention

Truvada (fixed dose combination of tenofovir + emtricitabine) + Stocrin (efavirenz), Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV), Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (Z

Status

Active, not recruiting

Source

The National Centre in HIV Epidemiology and Clinical Research

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:14-0400

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Medical and Biotech [MESH] Definitions

Inhibitor or Reverse Transcriptases or of RNA-dIrected DNA polymerase.

A pharmaceutical preparation of emtricitabine and tenofovir that is used as an ANTI-HIV AGENT in the treatment and prevention of HIV INFECTIONS.

A pharmaceutical preparation that contains emtricitabine, rilpivirine and tenofovir disoproxil fumarate. It is used to treat HIV INFECTIONS.

A pharmaceutical preparation of the ANTI-HIV AGENTS elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate that is used in the treatment of HIV INFECTIONS.

The use of multiple drugs administered to the same patient, most commonly seen in elderly patients. It includes also the administration of excessive medication. Since in the United States most drugs are dispensed as single-agent formulations, polypharmacy, though using many drugs administered to the same patient, must be differentiated from DRUG COMBINATIONS, single preparations containing two or more drugs as a fixed dose, and from DRUG THERAPY, COMBINATION, two or more drugs administered separately for a combined effect. (From Segen, Dictionary of Modern Medicine, 1992)

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