N/A N=18 Randomized Quadruple-blind Treatment

Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection

Acute HIV Infection

Bottom Line

View on ClinicalTrials.gov: NCT00734344 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcome: Primary: Mean White Blood Cell Count Between Treatment Groups at 2 Months — 5904; 4918 white blood cells per microliter (mcL).

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Raltegravir (Drug); Efavirenz (Drug); Emtricitibine (Drug); Tenofovir disoproxil once daily (Drug); Tenofovir disoproxil twice daily (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean White Blood Cell Count Between Treatment Groups at 2 Months	5904; 4918	—
PRIMARY Mean White Blood Cell Count Between Treatment Groups at 4 Months	5850; 4948	—
PRIMARY Mean White Blood Cell Count Between Treatment Groups at 6 Months	5219; 4522	—
PRIMARY Mean White Blood Cell Count Between Treatment Groups at 8 Months	6240; 4607	—
PRIMARY Mean White Blood Cell Count Between Treatment Groups at 10 Months	5230; 4615	—
PRIMARY Mean White Blood Cell Count Between Treatment Groups at 12 Months	6320; 4868	—
PRIMARY Mean White Blood Cell Count Between Treatment Groups at 14 Months	3180; 4903	—
PRIMARY Mean Hematocrit Between Treatment Groups at 2 Months	41.5; 41.8	—
PRIMARY Mean Hematocrit Between Treatment Groups at 4 Months	41.4; 43	—
PRIMARY Mean Hematocrit Between Treatment Groups at 6 Months	42.1; 39.8	—
PRIMARY Mean Hematocrit Between Treatment Groups at 8 Months	40.3; 41.2	—
PRIMARY Mean Hematocrit Between Treatment Groups at 10 Months	45; 38	—
PRIMARY Mean Hematocrit Between Treatment Groups at 12 Months	41; 43.5	—
PRIMARY Mean Hematocrit Between Treatment Groups at 14 Months	36; 39.7	—
PRIMARY Mean Platelet Count Between Treatment Groups at 2 Months	232600; 225600	—
PRIMARY Mean Platelet Count Between Treatment Groups at 4 Months	210800; 197300	—
PRIMARY Mean Platelet Count Between Treatment Groups at 6 Months	230000; 224800	—
PRIMARY Mean Platelet Count Between Treatment Groups at 8 Months	215700; 208100	—
PRIMARY Mean Platelet Count Between Treatment Groups at 10 Months	193500; 243300	—
PRIMARY Mean Platelet Count Between Treatment Groups at 12 Months	255600; 185500	—
PRIMARY Mean Platelet Count Between Treatment Groups at 14 Months	217400; 216800	—
PRIMARY Mean CD4 Count Between Treatment Groups at 1 Months	629.1; 535	—
PRIMARY Mean CD4 Count Between Treatment Groups at 2 Months	703.1; 527.2	—
PRIMARY Mean CD4 Count Between Treatment Groups at 3 Months	716.4; 671.7	—
PRIMARY Mean CD4 Count Between Treatment Groups at 4 Months	617.2; 646.5	—
PRIMARY Mean CD4 Count Between Treatment Groups at 5 Months	805.7; 539.6	—
PRIMARY Mean CD4 Count Between Treatment Groups at 6 Months	652.2; 673.5	—
PRIMARY Mean CD4 Count Between Treatment Groups at 7 Months	504; 552.5	—
PRIMARY Mean CD4 Count Between Treatment Groups at 8 Months	464.5; 586.5	—
PRIMARY Mean CD4 Count Between Treatment Groups at 9 Months	306; 571	—
PRIMARY Mean CD4 Count Between Treatment Groups at 10 Months	469; 571.5	—
PRIMARY Mean CD4 Count Between Treatment Groups at 11 Months	495	—

Summary

This is a single-site, investigator-initiated, open-label, randomized/controlled clinical trial to compare the viral load response in plasma (and, in a subset of subjects, in gastrointestinal lymphoid tissue reservoirs) in subjects with acute/early HIV-1 infection treated with 12 weeks of raltegravir-based versus efavirenz-based ART (each combined with tenofovir/emtricitabine). Subjects will receive a self-limited course of therapy rather than a commitment to life-long HAART, as has been the experimental approach in a variety of clinical protocols in the United States and Europe. Subjects will complete a 12 week course of therapy, and those who meet treatment-response and safety criteria will then undergo a similarly intensive period of virology and immunology monitoring to compare the timing and dynamics of any observed virologic rebound following the treatment intervention.

Eligibility Criteria

Inclusion Criteria

Subjects 19 years of age or older who meet the NIH Acute Infection and Early Disease Research Program (AIEDRP) definition of acute or early HIV-1 infection. Briefly, acute HIV-1 infection is defined as > 5000 copies per milliliter of HIV RNA and one of the following documented within a 7 day period of the initial positive PCR-based assay: 1) a negative HIV-1 EIA or 2) a positive EIA with a negative or indeterminant HIV-1 Western Blot test (interpreted based on current CDC guidelines). For the purposes of this protocol, early HIV-1 infection is defined as detectable HIV RNA by PCR-based assay, a positive HIV EIA, a positive HIV-1 Western blot, and one of the following: 1) a documented negative HIV EIA in the preceding 6 months or 2) an HIV detuned EIA standardized optical density measurement (defined as sample OD - negative control OD/ positive control OD) of 2.0 x upper limit of normal or a calculated creatinine clearance at time of screening 5 x upper limit of normal.
AST (SGOT) and ALT (SGPT) > 5 x upper limit of normal. Repeat of a laboratory screening test will be allowed for test results that are unexpected based on documented prior laboratory results or to monitor declining trends that may relate to the primary retroviral syndrome.
Have any severe medical illness that the investigators feel will interfere with the ability to take therapy or that will result in making therapy too risky for the subject. This includes active tuberculosis treatment, severe liver disease due to alcoholism or viral hepatitis, or unstable cardiovascular or cerebrovascular disease.
Have significant psychiatric illness or ongoing substance abuse that, in the opinion of the investigators, would compromise the ability of the subject to provide adequate informed consent or to adhere to the study procedures safely and consistently.
Women who are pregnant or actively breastfeeding at the time of screening.
Men or women who are actively attempting to become pregnant, or who are unable or unwilling to institute adequate birth control measures during the entire course of this treatment protocol.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00734344). 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.