The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Raltegravir Activity In Lymphoid Tissues

NCT00863668

HIV Infection HIV Infections

WITHDRAWN NA

Effects of Intensive cART During Acute/Early HIV Infection

NCT01154673

Acute HIV Infection

COMPLETED PHASE2/PHASE3

Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1

NCT00781287

Human Immunodeficiency Virus

TERMINATED PHASE4

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

NCT00734344

Acute HIV Infection

COMPLETED NA

Efficacy and Tolerance of the Switch From Enfuvirtine to Raltegravir in Antiretroviral Therapy Regimen in HIV Patients With Undetectable Viral Load

NCT00454337

HIV Infections

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study is an open-label study of 3-years duration. This study will be conducted at 4 study sites in Sydney, Australia. Sixteen participants will be recruited comprising 8 participants diagnosed with primary HIV infection (Cohort A) and 8 individuals with chronic HIV infection (Cohort B). All patients must be antiretroviral therapy (ART) naïve and will commence a regimen of combination ART consisting of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC; Truvada) plus the integrase inhibitor, raltegravir. Subjects will be followed for three years with intensive quantification of both plasma RNA and cell associated DNA viral species.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

antiretroviral therapy

tenofovir (TDF) + emtricitabine (FTC) as a fixed dose combination administered orally once per day and raltegravir (RAL) administered orally twice per day.

Group Type EXPERIMENTAL

Tenofovir + emtricitabine + raltegravir.

Intervention Type DRUG

TDF 300mg once daily + FTC 200mg once daily + RAL 400mg twice daily.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tenofovir + emtricitabine + raltegravir.

TDF 300mg once daily + FTC 200mg once daily + RAL 400mg twice daily.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TDF FTC RAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age at least 18 years.
* Provision of written, informed consent.
* Screening plasma HIV RNA \> 10,000 copies/mL.
* Screening CD4+ T lymphocyte count \> 100 x 10\^6)/L.
* No previous antiretroviral therapy.
* Haemoglobin \> 115 g/L (female) or \> 130 g/L (male).
* Absolute neutrophil count \> 1 x 10\^9/L.
* Platelet count \> 100 x 10\^9/L
* Serum bilirubin \< 1.5 x ULN.
* Serum alkaline phosphatase \< 3 X ULN.
* Serum aspartate aminotransferase (AST) \< 3 X ULN.
* Serum alanine aminotransferase (ALT) \< 3 X ULN.
* Creatinine clearance \> 50mL/min (Creatinine clearance (mL/min) =140 - age x weight creatinine Multiply the result by 1.2 for men).

Cohort A: Primary HIV infection:

Documented acute or early infection diagnosed by:

Acute infection:

\< 3 bands on Western Blot and any one of: i. positive p24 antigen ii. positive proviral DNA

Early infection:

i. Positive detuned or BED ELISA result OR ii. Previously negative serology within 6 months of confirmed positive serology.

Cohort B: Chronic HIV infection:

Documented HIV-infection of at least 12 months duration.

Exclusion Criteria

* Pregnancy or breastfeeding.
* Receipt of investigational products within 1 month of study entry.
* Receipt of any of the following within 6 months of study entry:

* interferon alpha or gamma
* oral corticosteroids (inhaled or topical corticosteroids are permitted)
* cyclosporin
* alkylating agents
* other immunosuppressive agents
* rifampin
* phenytoin
* phenobarbital
* Documented genotypic (IAS 2007) resistance to tenofovir or emtricitabine from any HIV drug resistance test.
* Any medications contraindicated with Truvada or raltegravir.
* Significant intercurrent illnesses apart from HIV infection such as viral hepatitis (diagnosed by core hepatitis B antigen and/or positive hepatitis B PCR or positive hepatitis C PCR) or any other condition which in the opinion of the investigator would compromise participation in the study.
* History of non-traumatic osteoporotic fracture.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No