A Phase 4 interventional study of Once daily in HIV Infections, sponsored by Oklahoma State University Center for Health Sciences. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-04.
Sponsored by Oklahoma State University Center for Health Sciences · Phase 4, Interventional, and Treatment
Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r, 800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to \<50 copies/ml in antiretroviral naïve patients through 48 weeks of therapy.
This study is a phase IV prospective, open-label, controlled treatment protocol consisting of once daily Kaletra dosed at 800mg lopinavir with 200mg ritonavir in four combination tablets plus Viread dosed as 300 mg tenofovir DF. This will be a single site, multi-investigator, study for 48 weeks. Consecutive eligible patients will be enrolled into the study to reach the enrollment goal of 30 patients. Eligible patients will be identified and screened during routine initial or follow-up visits at the Internal Medicine Specialty Services Clinic. This clinic serves as the HIV/AIDS specialty care clinic and is a subdivision of the Department of Internal Medicine, Oklahoma State University Center for Health Sciences College of Osteopathic Medicine. The study site currently serves >700 persons living with HIV in northeast Oklahoma with four to five antiretroviral naïve patients seen each week.
Patients meeting all inclusion criteria will receive routine standard of care for our program as prescribed by the DHHS guidelines. Patients will have a Complete Blood Count (CBC), Complete Metabolic Profile (CMP), fasting lipid profile, CD4 count, HIV-1 RNA level, and other prescribed or indicated laboratory preformed at baseline and throughout the study as described in the Visits and Evaluations section of this protocol. All of the aforementioned laboratory tests will be performed at the Diagnostic Laboratories of Oklahoma, a division of Quest Diagnostics. Any antiretroviral resistance testing will be performed at Virologic Labs, Inc. Adherence will be assessed at discontinuation of the study and when indicated for evaluation of virologic failure by Memory Electronic Monitoring Systems caps and pharmacy refill data. Patients will be monitored at each study visit for tolerability and adverse events. Patients who develop a study related Grade 1 or 2 Adverse Events (Aes) may continue the study. Those who develop Grade 3 or 4 AEs will have study medications discontinued. Patients with asymptomatic elevations of triglyceride or Low Density Lipoprotein (LDL) cholesterol levels may be treated with appropriate lipid lowering therapy at the investigators discretion.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 6 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Oklahoma State University Center for Health Sciences is the lead sponsor of 34 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Female patients must meet these additional criteria
Exclusion Criteria:
Presence of any of the following:
Patients taking 4 (four) lopinavir/ritonavir (200mg/50mg tablets) and 1 (one) tenofovir (300mg tablet) every 24 (twenty four) hours.
Drug: Once daily
Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily
Also known as: Kaletra, Viread
To Assess the Efficacy of Once Daily Antiretroviral Therapy With Viread 300mg and Kaletra 800mg/200mg in Suppressing HIV RNA Levels to <50 Copies/ml in Antiretroviral naïve Patients.
To assess the efficacy of once daily antiretroviral therapy with Viread 300mg and Kaletra 800mg/200mg in suppressing HIV RNA levels to \<50 copies/ml in antiretroviral naïve patients. This will be done by the proportion of patients with plasma HIV-1 RNA levels M 50 copies/ml at the end of 48 weeks of therapy.
Time frame: 4, 8, 12, 16, 24, 32, 40, and 48 weeks
Proportion of Patients With <400copies/ml
Proportion of patients with \<400copies/ml will be done by determining plasma HIV-1 RNA levels
Time frame: 4,8, and 12 weeks
Review Virologic Response to Assess Rate of Viral Decline.
Review virologic response to assess rate of viral decline through CD4 count at baseline and throughout the study.
Time frame: weeks 4, 8, 12, 16, and 24
Proportion of Patients With <50 Copies/ml HIV-1 RNA
Proportion of patients with \<50 copies/ml HIV-1 RNA through evaluation of patients Plasma HIV-1 RNA levels
Time frame: at weeks 4, 8, 12, 16, 24, 32, 40, and 48
Change From Baseline CD4 Counts
CD4 count done at baseline and throughout the study.
Time frame: at weeks 4, 8, 12, 16, 24, 32, 40, and 48
Time to Virologic Failure.
Virologic failure is defined by any of the following: 1) \<1 log10 decline in HIV RNA by week 8 of therapy; 2) failure to achieve \<50 c/mL by week 24; 3) HIV RNA\> 500 c/ML on two consecutive occasions (less than 30 days apart), with no evidence of suppression after adherence counseling. When HIV RNA levels are obtained \>500 copies/mL it will be repeated within 2 weeks. If after adherence counseling, HIV RNA demonstrates \> 1 log 10 decline but remains \>500, the patient will receive a final adherence counseling session and have his/her HIV RNA measure repeated at day 30: if a third consecutive HIV RNA remains 500 c/mL the patient will be removed from study, if \<500c/mL the patient will remain on study
Time frame: Week 48
Tolerability and Adverse Events.
Adverse events and safety parameters are monitored for ll subjects for the duration of the study. Toxicities and adverse events will be graded using the modified ACTG toxicity ratings scale. Study drugs may be interrupted for safety reasons and/or based on grade of toxicity/adverse event.
Time frame: 48 weeks
Change From Baseline Fasting Total Cholesterol and Fasting Triglyceride Levels.
Change from baseline fasting total cholesterol and fasting triglyceride levels will be measured by fasting lipid panels taken at baseline and at various timepoints.
Time frame: 48 weeks
Characterize Adherence Rates for This Therapeutic Regimen by the Use of Medication Electronic Monitoring Systems (MEMS) Caps.
The medication event monitoring system (MEMS) is a cap that fits on standard medicine bottles and records the time and date each time the bottle is opened and closed.
Time frame: 48 weeks
Characterize Adherence Rates for This Therapeutic Regimen by Use of Pharmacy Refill Records.
Characterize adherence rates for this therapeutic regimen by use of pharmacy refill records is assessed by an examination of pharmacy refill data for patients.
Time frame: 48 weeks
Assess Genotypic Changes in Patients With Virologic Failure.
At time of virologic failure genotypes will be performed on baseline and failure isolates; phenotypic testing will be performed on failure isolates to examine LPV susceptibility.
Time frame: 48 weeks
Assess Lopinavir Trough Levels in Patients Failing to Obtain Virologic Suppression.
Assess lopinavir trough levels in patients failing to obtain virologic suppression by measuring lopinavir trough level
Time frame: 48 weeks
Recruitment was July 2009 to January 2011 and was completed at the Internal Medicine Specialty Clinic at OSU-CHS.
| Milestone | Single Treatment Arm |
|---|---|
| Started | 15 |
| Completed | 2 |
| Not completed | 13 |
To assess the efficacy of once daily antiretroviral therapy with Viread 300mg and Kaletra 800mg/200mg in suppressing HIV RNA levels to \<50 copies/ml in antiretroviral naïve patients. This will be done by the proportion of patients with plasma HIV-1 RNA levels M 50 copies/ml at the end of 48 weeks of therapy.
No measurements were reported for this outcome.
Proportion of patients with \<400copies/ml will be done by determining plasma HIV-1 RNA levels
No measurements were reported for this outcome.
Review virologic response to assess rate of viral decline through CD4 count at baseline and throughout the study.
No measurements were reported for this outcome.
Proportion of patients with \<50 copies/ml HIV-1 RNA through evaluation of patients Plasma HIV-1 RNA levels
No measurements were reported for this outcome.
CD4 count done at baseline and throughout the study.
No measurements were reported for this outcome.
Virologic failure is defined by any of the following: 1) \<1 log10 decline in HIV RNA by week 8 of therapy; 2) failure to achieve \<50 c/mL by week 24; 3) HIV RNA\> 500 c/ML on two consecutive occasions (less than 30 days apart), with no evidence of suppression after adherence counseling. When HIV RNA levels are obtained \>500 copies/mL it will be repeated within 2 weeks. If after adherence counseling, HIV RNA demonstrates \> 1 log 10 decline but remains \>500, the patient will receive a final adherence counseling session and have his/her HIV RNA measure repeated at day 30: if a third consecutive HIV RNA remains 500 c/mL the patient will be removed from study, if \<500c/mL the patient will remain on study
No measurements were reported for this outcome.
Adverse events and safety parameters are monitored for ll subjects for the duration of the study. Toxicities and adverse events will be graded using the modified ACTG toxicity ratings scale. Study drugs may be interrupted for safety reasons and/or based on grade of toxicity/adverse event.
No measurements were reported for this outcome.
Change from baseline fasting total cholesterol and fasting triglyceride levels will be measured by fasting lipid panels taken at baseline and at various timepoints.
No measurements were reported for this outcome.
The medication event monitoring system (MEMS) is a cap that fits on standard medicine bottles and records the time and date each time the bottle is opened and closed.
No measurements were reported for this outcome.
Characterize adherence rates for this therapeutic regimen by use of pharmacy refill records is assessed by an examination of pharmacy refill data for patients.
No measurements were reported for this outcome.
At time of virologic failure genotypes will be performed on baseline and failure isolates; phenotypic testing will be performed on failure isolates to examine LPV susceptibility.
No measurements were reported for this outcome.
Assess lopinavir trough levels in patients failing to obtain virologic suppression by measuring lopinavir trough level
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Treatment Arm | — | 0/15 (0%) | 0/15 (0%) |
| Age, Categorical(Participants) | Single Treatment Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 0 |
| Age, Continuous(years) | Single Treatment Arm |
|---|---|
| Mean | 36 ± 12 |
| Sex: Female, Male(Participants) | Single Treatment Arm |
|---|---|
| Female | 2 |
| Male | 13 |
| Region of Enrollment(participants) | Single Treatment Arm |
|---|---|
| United States | 15 |
This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Oklahoma State University Center for Health Sciences