A Phase 2 interventional study of Kaletra + Isentress and Atripla in HIV Infections, sponsored by University of California, San Diego. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-22.
Sponsored by University of California, San Diego · Phase 2, Interventional, and Treatment
CCTG 589 is a randomized, open-label, pilot study comparing the efficacy, safety and tolerability of RAL plus LPV/r to EFV plus TDF/FTC in HIV-infected, treatment-naïve subjects. Subjects will be ineligible if they have any evidence of drug resistant virus in the past or at the time of screening (if never previously tested). Those who are found to be eligible will be randomized 1:1 to initiate either LPV/r (400/100 mg) plus RAL (400mg), both given twice-daily, or fixed dose combination of EFV (600 mg), TDF (300 mg) and FTC (200 mg) given as once-daily Atripla® for 48 weeks.
Hypotheses
The novel nucleoside-sparing combination of LPV/r + RAL will have a faster phase 1 viral decay rate compared to standard-of-care therapy with EFV/TDF/FTC in antiretroviral-naïve patients.
The purpose of this study is to determine how well a new anti-HIV drug combination (RAL plus LPV/r) taken twice a day decreases the amount of HIV found in participants' blood (viral load) compared to taking the once-a-day combination pill Atripla®. This study will also try to determine if the new combination has fewer side effects and is tolerated better than Atripla®. Another reason this study is being done is to see if this new drug combination helps participants' body's CD4 cells recover differently and will also look at how well participants' bodies absorbs these drugs and how safe these drugs are when given together.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 51 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Laboratory values obtained by screening laboratories within 30 days of entry:
Calculated creatinine clearance (CrCl) > 60 mL/min as estimated by the Cockcroft-Gault equation:
Exclusion Criteria:
Kaletra (lopinavir/ritonavir 400/100 mg) + Isentress (Raltegravir 400 mg) twice-daily
Drug: Kaletra + Isentress
Sustiva (EFV 600 mg), Viread (TDF 300 mg) and Emtriva (FTC 200 mg) taken as Atripla® once-daily
Drug: Atripla
kaletra 2 tabs twice a day + Raltegravir 1 tab twice a day
Also known as: Lopinavir/ritonavir (LPV/r) + Raltegravir (RAL)
Atripla 1 tab once a day
Also known as: Efavirenz (EFV) + Tenofovir Disoproxil Fumarate + Emtricitabine (TDF/FTC)
To Compare the Phase 1 Viral Decay Rates Between LPV/r + RAL vs. EFV/TDF/FTC Treatment Combinations.
Repeated HIV RNA measured at different time points (baseline, days 2, 7, 10, 14) will be treated as the outcome variable in a linear mixed-effects model. The primary fixed effects will include time, treatment group, treatment group-by-time interaction; random effects will include both intercept and slope allowing each subject to have individual baseline viral load and viral decay (rate of decrease in viral load following initiation of antiretroviral therapy). The treatment group-by- time interaction term in the model will indicate the difference in viral decay rates between the two treatment groups. Baseline covariate adjustment will be included if necessary.
Time frame: Baseline, days 2, 7, 10, 14
Viral Suppression Efficacy at 48 Weeks
To determine the antiviral efficacy of LPV/r + RAL compared to EFV/TDF/FTC after 48 weeks of treatment by achieving undetectable viral load
Time frame: 48 weeks
Compare Early Activated CD4+ T-cell Recovery Rates From Baseline to Week 4.
To compare early (baseline to Week 4) activated CD4+ T-cell recovery rates between treatment regimens.
Time frame: Baseline to Week 4
Compare Late Activated CD4+ T-cell Recovery Rates Between Treatment Regimens From Baseline to Week 48
To compare late (baseline to Week 48) activated CD4+ T-cell recovery rates between treatment regimens.
Time frame: 48 weeks
| Milestone | 1 - Kaletra + Isentress Taken Twice Daily | 2 - Atripla Taken Once Daily |
|---|---|---|
| Started | 26 | 25 |
| Completed | 26 | 24 |
| Not completed | 0 | 1 |
| Withdrew: Randomized but did not do viral kinetics | 0 | 1 |
Repeated HIV RNA measured at different time points (baseline, days 2, 7, 10, 14) will be treated as the outcome variable in a linear mixed-effects model. The primary fixed effects will include time, treatment group, treatment group-by-time interaction; random effects will include both intercept and slope allowing each subject to have individual baseline viral load and viral decay (rate of decrease in viral load following initiation of antiretroviral therapy). The treatment group-by- time interaction term in the model will indicate the difference in viral decay rates between the two treatment groups. Baseline covariate adjustment will be included if necessary.
| log(10)/day | 1 - Kaletra + Isentress Taken Twice Daily | 2 - Atripla Taken Once Daily |
|---|---|---|
| To Compare the Phase 1 Viral Decay Rates Between LPV/r + RAL vs. EFV/TDF/FTC Treatment Combinations. | 0.47 (0.42 to 0.52) | 0.55 (0.52 to 0.58) |
To determine the antiviral efficacy of LPV/r + RAL compared to EFV/TDF/FTC after 48 weeks of treatment by achieving undetectable viral load
| percentage of participants | 1 - Kaletra + Isentress Taken Twice Daily | 2 - Atripla Taken Once Daily |
|---|---|---|
| Viral Suppression Efficacy at 48 Weeks | 86 | 87.5 |
To compare early (baseline to Week 4) activated CD4+ T-cell recovery rates between treatment regimens.
| cells/mm^3 | 1 - Kaletra + Isentress Taken Twice Daily | 2 - Atripla Taken Once Daily |
|---|---|---|
| Compare Early Activated CD4+ T-cell Recovery Rates From Baseline to Week 4. | -3.81 (-6.12 to -1.51) | -1.18 (-3.17 to 0.08) |
To compare late (baseline to Week 48) activated CD4+ T-cell recovery rates between treatment regimens.
| cells/mm^3 | 1 - Kaletra + Isentress Taken Twice Daily | 2 - Atripla Taken Once Daily |
|---|---|---|
| Compare Late Activated CD4+ T-cell Recovery Rates Between Treatment Regimens From Baseline to Week 48 | -2.24 (-5.83 to 1.36) | -5.65 (-8.76 to -2.54) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1 - Kaletra + Isentress Taken Twice Daily | — | 0/26 (0%) | 13/26 (50%) |
| 2 - Atripla Taken Once Daily | — | 0/25 (0%) | 15/25 (60%) |
| Event | 1 - Kaletra + Isentress Taken Twice Daily | 2 - Atripla Taken Once Daily |
|---|---|---|
| Any CNS SymptomsNervous system disorders | 3/26 | 14/25 |
| GI SymptomsGastrointestinal disorders | 13/26 | 4/25 |
| RashSkin and subcutaneous tissue disorders | 3/26 | 8/25 |
| Pain, Aches & Muscle DiscomfortMusculoskeletal and connective tissue disorders | 4/26 | 5/25 |
| Generalized SymptomsGeneral disorders | 3/26 | 4/25 |
| Age, Continuous(years) | 1 - Kaletra + Isentress Taken Twice Daily | 2 - Atripla Taken Once Daily | Total |
|---|---|---|---|
| Median | 40 (30.3 to 47.5) | 43 (32.7 to 47.8) | 43 (31 to 48) |
| Sex: Female, Male(Participants) | 1 - Kaletra + Isentress Taken Twice Daily | 2 - Atripla Taken Once Daily | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 25 | 24 | 49 |
| Race/Ethnicity, Customized(Participants) | 1 - Kaletra + Isentress Taken Twice Daily | 2 - Atripla Taken Once Daily | Total |
|---|---|---|---|
| White | 21 | 22 | 43 |
| Black | 5 | 0 | 5 |
| Asian | 0 | 1 | 1 |
| Other | 0 | 2 | 2 |
| Hispanic | 12 | 14 | 26 |
| Non-Hispanic | 14 | 11 | 25 |
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University of California, San Diego