Study of Viral Load Decay Rates in HIV Infected Participants Starting Treatment With Raltegravir (RAL) and Emtricitabine/Tenofovir Disoproxil Fumarate (TDF)

Study Overview
=================
Brief Summary
-----------------
The HIV integrase inhibitor, raltegravir (RAL), which was recently approved by the FDA, has been shown in several trials to be highly effective. The purpose of this trial is to estimate the viral load decay rate in treatment-naive HIV infected participants receiving RAL and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).

Detailed Description
-----------------
Recent data suggests that early virologic response to HIV interventions may be predictive of long-term virologic outcomes. Defining early decay in viral load through carefully performed studies of viral dynamics may be a useful tool for assessing the likely outcome of long-term treatment. It may also be a useful screening tool to define which combinations should be studied further. In this trial, the viral load decay rate will be estimated in HIV infected, treatment-naive participants receiving RAL and FTC/TDF. This study will last approximately 72 weeks. All participants will take RAL and FTC/TDF for 72 weeks. RAL will be provided by the study. FTC/TDF will not be provided. This study will consist of 16 study visits. These visits will occur at study entry, Days 2, 7, 10, 14, 21, 28, and 56, and Weeks 12, 16, 20, 24, 36, 48, 60, and 72. Blood collection and pharmacokinetic studies will occur at all study visits. Self-reported adherence assessments will be submitted at each visit. A targeted physical exam will occur at most visits. Liver function tests and urine collection will occur at select visits. Pregnancy tests will occur whenever pregnancy is suspected.

Official Title
-----------------
First-Phase Viral Decay Rates in Treatment-Naive Subjects Initiating Treatment With Raltegravir (RAL) and Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF): A Pilot Study

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Raltegravir
* Drug: Emtricitabine/tenofovir disoproxil fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected Antiretroviral treatment naive Viral load at least 10,000 and less than 300,000 copies/ml within 42 days prior to study entry Agree to use appropriate form of contraception. More information on this criterion can be found in the protocol. Exclusion Criteria: Received HIV-specific immunizations within 6 months prior to study entry Received immunizations within 6 months prior to study entry Known allergy or sensitivity to study drugs Any participant with an acute AIDS-defining opportunistic infection (OI) who is not clinically stable or who has not been on therapy for the OI for at least 30 days prior to study entry Treatment with immune modulators or any investigational therapy within 30 days prior to study entry Evidence of HIV seroconversion within 6 months prior to study entry Illness requiring systemic treatment and/or hospitalization Substance abuse that, in the opinion of the investigator, would interfere with adherence to study requirements Requirement for any current medications that are prohibited with any study medication. More information on this criterion can be found in the protocol. Evidence of any major resistance-associated mutation on any genotype performed prior to study entry or at the time of screening. More information on this criterion can be found in the protocol. Abnormal laboratory values. More information on this criterion can be found in the protocol. Pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oral RAL and FTC/TDF for 72 weeks | Drug: Raltegravir<br>* 400 mg tablet taken orally twice daily<br>* Other names: RAL;Drug: Emtricitabine/tenofovir disoproxil fumarate<br>* Fixed dose tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate taken once daily. FTC/TDF will not be provided by the study and must be obtained by the particpant's health care provider.<br>* Other names: FTC/TDF;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load decay rates |  | Through Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load decay rates |  | From Weeks 24 to 72 | 
| Proportion of participants with a viral load less than 50 copies/ml |  | At Weeks 24, 48, and 72 | 
| Safety and tolerability. More information on this criterion can be found in the protocol. |  | Throughout study | 
| CD4 and CD8 count |  | Throughout study | 
| Resistance mutations to RAL, FTC, and TDF |  | Throughout study | 
| Minimum concentration (Cmin) for RAL, FTC, and TDF |  | Throughout study | 
| Changes in viral load |  | At Day 7 | 
| Self-reported adherence |  | Throughout study | 
| Cell-associated proviral DNA, LTR circular DNA, and integrated proviral DNA |  | Throughout study | 
| Viral load |  | From Week 24 to Week 72 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Integrase Inhibitors, HIV Nucleoside Reverse Transcriptase Inhibitors, Treatment Naive, Viral Load