A Phase 4 interventional study of Raltegravir and truvada and Atazanavir, Norvir and Truvada in HIV Infections, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-05.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Treatment
This is a pilot that will evaluate two regimens for treating HIV infected patients that haven't been on treatment before. HIV/AIDS patients may have an increased risk of myocardial infarction and antiretroviral therapy used may contribute to this. We will evaluate virological, immunological and cardiovascular effects of two HIV treatment regimens.
We will check blood studies used to evaluate HIV patients response to therapy including CD4 count and HIV viral load test. We will check routine safety labs done on HIV patients and also check homocysteine levels and creatine kinase level. We will evaluate homocysteine and IL6 levels at baseline, week 48, and week 96.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 33 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Raltegravir in combination with truvada (tenofovir and emtricitabine)
Drug: Raltegravir and truvada
Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
Drug: Atazanavir, Norvir and Truvada
Raltegravir 400 mg po bid, truvada 1 tab q daily
Also known as: Truvada is tenofovir 300 mg and emtricitabine 200 mg
Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
Also known as: Truvada is tenofovir 300 mg and emtricitabine 200 mg
Change From Baseline in CD4 Count at 48 Weeks
Time frame: Baseline and 48 weeks
Change From Baseline in Log HIV Viral Load at 48 Weeks
Time frame: Baseline and 48 weeks
Change From Baseline in Lipids at 48 Weeks
Time frame: Baseline and 48 weeks
Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks
Time frame: Baseline and 48 weeks
Change From Baseline in Homocysteine at 6 Months
Time frame: Baseline and 48 weeks
approached patients HIV positive, naive to therapy, single site, English and Spanish speaking/writing.
| Milestone | Raltegravir | Atazanavir |
|---|---|---|
| Started | 14 | 14 |
| Completed | 9 | 8 |
| Not completed | 5 | 6 |
| Withdrew: Lost to follow-up | 2 | 5 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Pregnancy | 1 | 0 |
| Withdrew: Incarceration | 1 | 0 |
| cells/uL | Raltegravir | Atazanavir |
|---|---|---|
| Change From Baseline in CD4 Count at 48 Weeks | 192 ± 26 | 205 ± 27 |
| mg/dL | Raltegravir | Atazanavir |
|---|---|---|
| Total cholesterol | -0.25 ± 7.66 | 8.13 ± 11.96 |
| Triglycerides | -15.50 ± 18.47 | 16.88 ± 40.89 |
| HDL cholesterol | -1.5 ± 2.58 | -1.38 ± 3.08 |
| LDL cholesterol | 4.13 ± 7.54 | 5.88 ± 14.46 |
| copies/mL | Raltegravir | Atazanavir |
|---|---|---|
| Change From Baseline in Log HIV Viral Load at 48 Weeks | -3.05 ± 0.28 | -3.29 ± 0.26 |
| pg/mL | Raltegravir | Atazanavir |
|---|---|---|
| Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks | -2.71 ± 1.63 | -4.47 ± 2.51 |
| umol/L | Raltegravir | Atazanavir |
|---|---|---|
| Change From Baseline in Homocysteine at 6 Months | 0.53 ± 0.83 | 0.10 ± 0.94 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Raltegravir | — | 1/14 (7.1%) | — |
| Atazanavir | — | 0/14 (0%) | — |
| Event | Raltegravir | Atazanavir |
|---|---|---|
| MAI infection, multi-organ failure, deathRenal and urinary disorders | 1/14 | 0/14 |
| Age, Categorical(Participants) | Raltegravir | Atazanavir | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 14 | 28 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(year) | Raltegravir | Atazanavir | Total |
|---|---|---|---|
| Mean | 40.7 ± 11 | 38.8 ± 10 | 39.8 ± 10.4 |
| Sex: Female, Male(Participants) | Raltegravir | Atazanavir | Total |
|---|---|---|---|
| Female | 7 | 3 | 10 |
| Male | 7 | 11 | 18 |
| Region of Enrollment(participants) | Raltegravir | Atazanavir | Total |
|---|---|---|---|
| United States | 14 | 14 | 28 |
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston