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

National Institute of Allergy and Infectious Diseases (NIAID) logo

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase

Completed
Phase 1

Conditions

HIV Infections

Treatments

Drug: Raltegravir
Drug: Emtricitabine/tenofovir disoproxil fumarate

Study type

Interventional

Funder types

NETWORK
NIH

Identifiers

NCT00660972
ACTG A5248
A5248
10532 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

1
Experimental group
Description:
Oral RAL and FTC/TDF for 72 weeks
Treatment:
Drug: Emtricitabine/tenofovir disoproxil fumarate
Drug: Raltegravir

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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