N/A Completed N=58 Randomized Treatment

Pilot Study of a Raltegravir Based NRTI Sparing Regimen

Acquired Immune Deficiency Syndrome · AIDS · Human Immunodeficiency Virus Infection · HIV

Source: ClinicalTrials.gov NCT00814879 ↗

Enrolled (actual)

Serious AEs

15.5%

Results posted

Feb 2016

Primary outcomePrimary: Number of Patients Reaching Virologic Failure at Week 48. — 2; 3 participants

Summary

This pilot study will provide data on the safety and efficacy of the combination of Raltegravir (RAL) 400mg BID + Atazanavir (ATV) 300 mg BID in Antiretroviral (ARV)-experienced subjects that have a suppressed HIV viral load on a Ritonavir (RTV) boosted Protease Inhibitor (PI) based regimen who are then switched to a regimen of RAL 400mg BID +ATV 300mg BID.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Reaching Virologic Failure at Week 48.	2; 3	—
SECONDARY Number of Patients With < 400 Copies HIV RNA/mL at Week 48	22; 21	—
SECONDARY CD4+ Cell Count	596.6; 665.9	—
SECONDARY CD4+ Cell Count	596.6; 665.9	—
SECONDARY Cholesterol	166.25; 178.83; 168.07; 169.65; 167.41; 174.48	—
SECONDARY Mean Change in Total Bilirubin (mg/dL) From Baseline	-0.15; 0.37	—

Eligibility Criteria

Inclusion Criteria

HIV-1 positive
On stable ARV-therapy for a minimum of 4 months with a HIV viral load of 18 years of age
Written informed consent
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria

Prior exposure to Raltegravir or Elvitegravir
A detectable HIV viral load >50 copies within the last 4 months
An ARV change within the last 4 months
History of PI drug resistance
Prior virologic failure on an ATV containing regimen
Prior history of intolerance to ATV
Pregnant or nursing mothers
Pre-existing grade 3 or above laboratory toxicity except for lipids:
Absolute neutrophil count (ANC) 5 x ULN.
Serum bilirubin > 5 x ULN.
calculated creatinine clearance of <50mL/min/1.73m2
Patients with chronic active hepatitis B infection defined by positive serum Hbs antigen
Use of any prohibited medications and/or the use of proton pump inhibitors in ATV plus RAL containing regimens)
Patients with current alcohol or illicit substance use that in judgment of investigator makes study adherence unlikely

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00814879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.