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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660972
• Other study ID #: A5248
• Secondary ID: 10532ACTG A5248
• Status: Completed
• Phase: Phase 1
• Start date: May 2008
• Est. completion date: April 2010

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Raltegravir
400 mg tablet taken orally twice daily
• Emtricitabine/tenofovir disoproxil fumarate
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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital CRS	Aurora	Colorado
United States	IHV Baltimore Treatment CRS	Baltimore	Maryland
United States	Johns Hopkins University CRS	Baltimore	Maryland
United States	Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS	Boston	Massachusetts
United States	Northwestern University CRS	Chicago	Illinois
United States	MetroHealth CRS	Cleveland	Ohio
United States	Ohio State University CRS	Columbus	Ohio
United States	Houston AIDS Research Team CRS	Houston	Texas
United States	Vanderbilt Therapeutics (VT) CRS	Nashville	Tennessee
United States	Harlem ACTG CRS	New York	New York
United States	The Miriam Hospital Clinical Research Site (TMH CRS) CRS	Providence	Rhode Island
United States	Trillium Health ACTG CRS	Rochester	New York
United States	Univ. of Rochester ACTG CRS	Rochester	New York
United States	Washington University Therapeutics (WT) CRS	Saint Louis	Missouri
United States	UCSD Antiviral Research Center CRS	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Adult AIDS Clinical Trials Group

Country where clinical trial is conducted

United States, 

References & Publications (2)

Evering TH, Markowitz M. Raltegravir: an integrase inhibitor for HIV-1. Expert Opin Investig Drugs. 2008 Mar;17(3):413-22. doi: 10.1517/13543784.17.3.413 . Review. — View Citation

Sedaghat AR, Dinoso JB, Shen L, Wilke CO, Siliciano RF. Decay dynamics of HIV-1 depend on the inhibited stages of the viral life cycle. Proc Natl Acad Sci U S A. 2008 Mar 25;105(12):4832-7. doi: 10.1073/pnas.0711372105. Epub 2008 Mar 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral load decay rates		Through Day 56
Secondary	Viral load decay rates		From Weeks 24 to 72
Secondary	Proportion of participants with a viral load less than 50 copies/ml		At Weeks 24, 48, and 72
Secondary	Safety and tolerability. More information on this criterion can be found in the protocol.		Throughout study
Secondary	CD4 and CD8 count		Throughout study
Secondary	Resistance mutations to RAL, FTC, and TDF		Throughout study
Secondary	Minimum concentration (Cmin) for RAL, FTC, and TDF		Throughout study
Secondary	Changes in viral load		At Day 7
Secondary	Self-reported adherence		Throughout study
Secondary	Cell-associated proviral DNA, LTR circular DNA, and integrated proviral DNA		Throughout study
Secondary	Viral load		From Week 24 to Week 72

External Links

•   Haga clic aquí para ver información sobre este ensayo clínico en español.