E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020161 |
E.1.2 | Term | HIV infection |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate whether HIV PHPC counts measured at week 9 during maximally suppressive HAART in HIV+ adults is higher in subjects receiving DermaVir Patches treatment than in Placebo subjects |
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E.2.2 | Secondary objectives of the trial |
To determine whether subjects on fully-suppressive HAART who develop increases in HIV-specific PHPC have lower HIV-1 RNA during ATI (defined as the geometric mean of HIV-1 RNA obtained at Week 16and Week 20) than subjects who do not increase PHPC To investigate whether HIV-specific PHPC counts measured during maximally suppressive HAART correlate with a lower Viral Load Time Averaged Area Under the Curve (TA-AUC) during ATI To determine if subjects who experience an increase in PHPC Gag p17 counts &#8805; 2,000 and/or PHPC total Gag counts &#8805; 5,000 prior to ATI are more likely to maintain HIV-1 RNA levels a.) below 400 copies/mL b.) below 5,000 copies/mL c.) lower than prior to HAART treatment at 16 and 20 weeks of an ATI than subjects who have PHPC Gag p17 counts < 2,000 and/or PHPC total Gag counts < 5,000 prior to ATI |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
HIV-1-infected adults; Age: &#8805;18 years and <50 years Provide written informed consent On a non-hydroxyurea based HAART for at least one year Pre-HAART CD4 nadir > 250 cells/mm3 Pre-HAART viral load > 5,000 copies/mL At least two viral load and two CD4 measurement for determination of nadir prior to HAART initiation Undetectable viral load (i.e., three or more determinations of < 50 copies/mL with no values of &#8805; 50 copies/mL) for the six month period preceding the study CD4 T-cell count >500 cells/mm3 for the six month period preceding the study Patient willing to comply with study regimen/Analytical Treatment Interruption Female study volunteers who are participating in sexual activity that could lead to pregnancy must agree to not become pregnant and use two methods of contraception, including at least one form of barrier contraception, while receiving DermaVir/Placebo and for 6 months after the last administration. Medically acceptable contraceptives include: Approved hormonal contraceptives, such as birth control pills, Depo-Provera, or Lupron Depot Barrier methods (such as condom or diaphragm) used with a spermicide Consult the CDC guidelines on the use of spermicide in this population Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV-1 transmission. An intrauterine device (IUD) Sexually active female study volunteers without reproductive potential are eligible without requiring the use of contraception. Written or oral documentation communicated by clinician or clinicians staff of one of the following is required for participants: physician report/letter, discharge summary. All male subjects participating in the study must agree to not attempt to impregnate a female or participate in sperm donation programs. Males engaging in sexual activity that could lead to pregnancy must use a condom while receiving DermaVir/Placebo and for 6 months after the last administration. Patient willing to comply with study regimen. Patient able and willing to provide signed informed consent. |
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E.4 | Principal exclusion criteria |
Skin disease such as: active atopic dermatitis active or history of psoriasis active urticaria Known hypersensitivity to adhesive tape or Tegaderm History of keloid (hypertrophic scar) at the skin treatment sites Active or history of vitiligo Melasma (acquired hyperpigmentation disorder) Skin cancer, including: Basal cell carcinoma Squamous cell carcinoma Melanoma Kaposis sarcoma Tattoos or changes in pigment at the skin treatment sites Active acute or chronic immune-compromising illness, including but not limited to: diagnosis of any chronic autoimmune disease clinically significant bleeding disorder diabetes mellitus requiring insulin and/or drug therapy Hepatitis B Antigen S at baseline Detectable hepatitis C RNA at baseline Treatment with any immune modulating agents or chemotherapy within 12 months prior to study Receipt of any immune globulin or blood products within three months prior to study Any vaccination within 28 days of study initiation Anticipation of any vaccination during the of the study Any interruption in HAART of > 7 consecutive days within 1 year of study entry History of lymph node irradiation Any malignancy within 12 months prior to screening Systemic steroid therapy within the past two months Pregnancy or Breast-feeding Values greater than or equal to Grade 2 in the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (Version 1.0 [December 2004], http://rcc.tech-res-intl.com) for any of the following laboratory tests at screening will be excluded [Grade 2 value and standard international units in italics] Hemoglobin (Hgb) [&#8804;8.4 g/dL] Absolute neutrophil count (ANC) [&#8804;999/mm3, &#8804;0.999 x 109/L] Platelets, decreased [&#8804;99,999/mm3, &#8804;99.999 x 109/L] Liver Function Tests (LFTs)-ALT (SGPT)/AST (SGOT) [&#8805;2.6 x ULN] Creatinine [&#8805;1.4 x ULN]-use age and sex appropriate values (per DAIDS Table) Lipase and pancreatic amylase [&#8805;1.6 x ULN] Total bilirubin [&#8805;1.6 x ULN]. NOTE: Subjects with total bilirubin &#8805; 1.6 x ULN, receiving Indinavir and/or Atazanavir with an Alkaline Phosphatase less than or equal to 1.0 x ULN are eligible. Excessive exposure to the sun (sunbathing, tanning beds) or any type of hair removal, tattoo removal, etc. at or in close proximity to the treatment site (patch areas) within 14 days prior to study entry. Close proximity is defined as: within 2 cm (about Ÿ of an inch) of the treatment site or close enough to the treatment site that an overlap cannot be ruled out. Any condition or history of illness, including drug or alcohol abuse that, in the opinion of the investigator, might interfere with the evaluation of the study objectives |
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E.5 End points |
E.5.1 | Primary end point(s) |
PHPC counts at study Week 9 during HAART |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |