A Phase 4 interventional study of Kaletra + Isentress and Pre-study antiretroviral regimen in HIV Infections, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-12.
Sponsored by Emory University · Phase 4, Interventional, and Treatment
This study will examine the effectiveness and safety of raltegravir (isentress) when used together with lopinavir/ritonavir (kaletra) for the treatment of HIV-infection. Isentress is a recently, Food and Drug Administration (FDA) approved, HIV medication that has strong effects against the HIV virus. Isentress has been shown in other studies to be safe and well tolerated by HIV patients. Combining this drug with kaletra might enable us to construct a HIV regimen that does not include the more toxic drugs of the nucleoside reverse transcriptase inhibitor class.
Eligible volunteers will undergo the following as part of the study procedure:
Information collected will be used to assess the effectiveness of this treatment in keeping the HIV virus suppressed, how well these two drugs together is tolerated by HIV-infected patients, and the blood levels of these two drugs when given together.
RATIONALE: Virologic failure and adverse effects associated with current highly active antiretroviral therapy (HAART) warrant continuing search for novel combination therapeutic options. Raltegravir's (RAL) was recently shown to be a potent antiretroviral (ARV) agent with a favorable safety profile. If future reports continue to show positive data on this first-in-class integrase inhibitor, there may be a paradigm shift in the currently recommended first line HAART to regimens that will include integrase inhibitors.
Combining RAL with a drug that has a high genetic barrier to resistance, such as lopinavir/ritonavir (LPV/r) may offer a number of advantages. Both agents are potent and should produce durable virologic suppression. Because their combination is reverse transcriptase inhibitor (RTI) class sparing, its tolerability might be superior. In addition, RAL is not metabolized by the cytochrome P-450 enzymes, therefore, a compatible pharmacokinetic profile is expected with this combination. Pairing LPV/r with RAL in early ARV regimens as is proposed in this application may provide a HAART regimen that is highly efficacious and durable, with less resistance and adverse drug events.
DESIGN: This is single center, open label, randomized, controlled, study designed to assess the tolerability, pharmacokinetic compatibility, and the durability of virologic suppression of the RTI sparing combination therapy of LPV/r + RAL. HIV-infected subjects who are virologically suppressed (HIV-RNA PCR \< 50 copies/ml) on current HAART regimen will be randomized in a 2:1 fashion to be switched to a regimen consisting of LPV/r + RAL, intervention arm A (n=40), or to be continued on their pre-study HAART regimen, control arm B (n=20). The primary endpoint will be proportion of subjects with sustained virologic suppression (HIV-1 RNA PCR \< 50 copies/ml) through week 48. The immunoreconstitution, toxicity profile, and pharmacokinetic profile of the RAL and LPV/r in this novel combination therapy will be evaluated.
DURATION: 48 weeks after the enrollment of the last participant. Enrollment is expected to take about 10 months.
SAMPLE SIZE: 60 subjects.
POPULATION: HIV-infected individuals (male and female), Age > 18 years, who are virologically suppressed (HIV-RNA PCR \< 50 copies/ml) on their current HAART regimen for > 6 months.
REGIMEN: For Arm A= LPV/r 400/100 mg (2 tablets) twice daily + RAL 400 mg (1 tablet) twice daily taken by mouth. For Arm B=Pre-study HAART regimen.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 60 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
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Laboratory values obtained within 30 days prior to study entry:
Exclusion Criteria:
Kaletra + Isentress
Drug: Kaletra + Isentress
Pre-study Antiretroviral regimen
Drug: Pre-study antiretroviral regimen
Kaletra 400/100 mg + Isentress 400 mg BID
Also known as: Raltegravir, Lopinavir/ritonavir
Standard doses of pre-study antiretroviral regimen
Also known as: HAART
Plasma Viral Loads (HIV-1 RNA PCR)
Percentage subjects with undetectable Plasma viral loads
Time frame: baseline to week 48
To Compare Plasma Triglyceride Levels at 48 Weeks Between LPV/r + RAL and Standard HAART Treated Subjects
Time frame: 48 weeks
All subjects were recruited from an urban outpatient HIV clinic (the Grady Infectious Diseases Program Out-patient Clinic, Atlanta, Georgia) between June 2008 and January 2011.
| Milestone | Kaletra + Isentress | Standard HAART |
|---|---|---|
| Started | 40 | 20 |
| Completed | 39 | 19 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| mg/dL | Kaletra + Isentress | Standard HAART |
|---|---|---|
| To Compare Plasma Triglyceride Levels at 48 Weeks Between LPV/r + RAL and Standard HAART Treated Subjects | 238.1 ± 19.9 | 133.3 ± 27.1 |
Percentage subjects with undetectable Plasma viral loads
| percentage of subjects | Kaletra + Isentress | Standard HAART |
|---|---|---|
| Plasma Viral Loads (HIV-1 RNA PCR) | 92.7 (83 to 100) | 88 (75 to 100) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Kaletra + Isentress | — | 0/39 (0%) | 0/39 (0%) |
| Standard HAART | — | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Kaletra + Isentress | Standard HAART | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 40 | 20 | 60 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Kaletra + Isentress | Standard HAART | Total |
|---|---|---|---|
| Mean | 46 ± 9 | 48 ± 12 | 47 ± 10 |
| Sex: Female, Male(Participants) | Kaletra + Isentress | Standard HAART | Total |
|---|---|---|---|
| Female | 14 | 8 | 22 |
| Male | 26 | 12 | 38 |
| Region of Enrollment(participants) | Kaletra + Isentress | Standard HAART | Total |
|---|---|---|---|
| United States | 40 | 20 | 60 |
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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