Conditions

HIV Infections

Keywords

HIV-1 treatment naive

Outcome Measures

Primary Outcomes (2)

The Proportion Of Participants With Virologic Response For 10 mg/Day Elvucitabine In HIV-1-Infected Participants By 12 Weeks Compared With The Proportion Of Participants With Lamivudine 300 mg/Day
The proportion of participants having achieved a virologic response for elvucitabine 10 mg/day in combination with efavirenz and tenofovir in HIV-1-infected participants over 12 weeks compared with the proportion of participants having achieved a virologic response for lamivudine 300 mg/day in combination with efavirenz and tenofovir. Virologic response was defined as having achieved undetectable (\<50 copies/mL) HIV-1 RNA levels from baseline assessment.
12 weeks
The Safety Profile Of Elvucitabine.
Determination of the safety profile of elvucitabine as defined by the frequency, type and severity of treatment-emergent adverse events (AEs) and the frequency of Grade 3 and Grade 4 laboratory abnormalities.
12 weeks

Study Arms (2)

Elvucitabine, Efavirenz, Tenofovir

EXPERIMENTAL

Elvucitabine (blinded) 10 milligrams (mg)/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible participants continued with an additional 84 weeks of open-label treatment (through Week 96). Participants who experienced at least a 2 log10 decrease in HIV-1 RNA from Baseline or who had an HIV-1 RNA level of less than 400 copies/ mL at Week 10 and had not experienced any Grade 3 or 4 hematological toxicity as of the Week 10 measurement were considered eligible for an additional 84 weeks of open-label treatment after Week 12.

Drug: ElvucitabineDrug: TenofovirDrug: Efavirenz

Lamivudine, Efavirenz, Tenofovir

ACTIVE COMPARATOR

Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible participants continued with an additional 84 weeks of open-label treatment (through Week 96). Participants who experienced at least a 2 log10 decrease in HIV-1 RNA from Baseline or who had an HIV-1 RNA level of less than 400 copies/mL at Week 10 and had not experienced any Grade 3 or 4 hematological toxicity as of the Week 10 measurement were considered eligible for an additional 84 weeks of open-label treatment after Week 12.

Interventions

ElvucitabineDrug

Elvucitabine 10 mg orally daily

Also known as: ACH-126,443

Elvucitabine, Efavirenz, Tenofovir

LamivudineDrug

Lamivudine 300 mg orally daily

Also known as: 3TC

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

A participant must meet the following criteria at Screening to be enrolled in this study:
Are male or female. Sexually active men with partners of childbearing potential must agree to use an acceptable form of contraception as determined by the investigator (for example, oral contraceptives, double-barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or vasectomy) during participation in the study. Female participants cannot be pregnant or lactating/breast-feeding and must be surgically sterile, postmenopausal as defined later, or practicing an effective method of birth control as determined by the investigator (for example oral contraceptives, double-barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy). A woman may be considered postmenopausal if she is at least 50 years or older, has a history of no menses for at least 12 months, and has a follicle-stimulating hormone (FSH) level over the upper limit of normal for reproductive aged women.

Sponsors & Collaborators

Achillion, a wholly owned subsidiary of Alexion
Industrycollaborator
Alexion Pharmaceuticals, Inc.
Industrylead

Study Sites (26)

Clinical Trial Site

Little Rock, Arkansas, 72207, United States

Clinical Trial Site

Long Beach, California, 90813, United States

Clinical Trial Site

Los Angeles, California, 90069, United States

Clinical Trial Site

Washington D.C., District of Columbia, 20007, United States

Clinical Trial Site

Clearwater, Florida, 33765, United States

Clinical Trial Site

Fort Myers, Florida, 33901, United States

Clinical Trial Site

Miami, Florida, 33133, United States

MeSH Terms

Conditions

HIV Infections

Interventions

dexelvucitabineLamivudineTenofovirefavirenz

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus Diseases

Results Point of Contact

Title: Alexion Pharmaceuticals Inc.
Organization: Alexion Pharmaceuticals Inc.

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-naive Participants

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Elvucitabine, Efavirenz, Tenofovir

Lamivudine, Efavirenz, Tenofovir

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (26)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Elvucitabine, Efavirenz, Tenofovir

Lamivudine, Efavirenz, Tenofovir

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (26)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations